Pub Date : 2025-11-01DOI: 10.12968/jowc.2025.34.Sup11b.S1
Leticia Vallejo-Carmona
Background: Negative pressure wound therapy (NPWT) has revolutionised the management of complex wounds via mechanisms such as microdeformation, angiogenesis and exudate control. However, its clinical effect has historically only been evaluated by qualitative and visual parameters. This study integrates near-infrared spectroscopy (NIRS) as a biofeedback tool to quantify physiological response to NPWT in real time.
Objective: This study aimed to quantitatively demonstrate the physiological and structural changes induced by an NPWT system in patients with complex wounds, measured using NIRS.
Methods: A prospective real-world observational study was conducted with a cohort of 23 patients with 33 wounds. Structural and physiological parameters were documented before and after NPWT treatment. Random-intercept mixed-effect statistical models and pre-post comparison tests were used to assess clinical and physiological significance.
Results: The data showed a progressive reduction in wound area and volume, accompanied by an increase in tissue oxygen saturation and a sustained decrease in deoxygenated haemoglobin. These findings, objectively quantified through NIRS as a real-time biofeedback tool, highlight the improvement in oxygenation and wound-bed perfusion and support the hypothesis of tissue biomodulation induced by NPWT.
Conclusion: The integration of NIRS redefines the clinical role of NPWT, allowing therapy to be customised based on specific physiological data. This combination represents a new frontier in precision wound medicine. The results of this study provide a foundation for a new generation of clinical decisions in advanced wound management.
{"title":"Structure-guided negative pressure wound therapy (NPWT): personalised tissue biomodulation with an NPWT system in adults and older adults.","authors":"Leticia Vallejo-Carmona","doi":"10.12968/jowc.2025.34.Sup11b.S1","DOIUrl":"10.12968/jowc.2025.34.Sup11b.S1","url":null,"abstract":"<p><strong>Background: </strong>Negative pressure wound therapy (NPWT) has revolutionised the management of complex wounds via mechanisms such as microdeformation, angiogenesis and exudate control. However, its clinical effect has historically only been evaluated by qualitative and visual parameters. This study integrates near-infrared spectroscopy (NIRS) as a biofeedback tool to quantify physiological response to NPWT in real time.</p><p><strong>Objective: </strong>This study aimed to quantitatively demonstrate the physiological and structural changes induced by an NPWT system in patients with complex wounds, measured using NIRS.</p><p><strong>Methods: </strong>A prospective real-world observational study was conducted with a cohort of 23 patients with 33 wounds. Structural and physiological parameters were documented before and after NPWT treatment. Random-intercept mixed-effect statistical models and pre-post comparison tests were used to assess clinical and physiological significance.</p><p><strong>Results: </strong>The data showed a progressive reduction in wound area and volume, accompanied by an increase in tissue oxygen saturation and a sustained decrease in deoxygenated haemoglobin. These findings, objectively quantified through NIRS as a real-time biofeedback tool, highlight the improvement in oxygenation and wound-bed perfusion and support the hypothesis of tissue biomodulation induced by NPWT.</p><p><strong>Conclusion: </strong>The integration of NIRS redefines the clinical role of NPWT, allowing therapy to be customised based on specific physiological data. This combination represents a new frontier in precision wound medicine. The results of this study provide a foundation for a new generation of clinical decisions in advanced wound management.</p>","PeriodicalId":17590,"journal":{"name":"Journal of wound care","volume":"34 Sup11b","pages":"S1-S23"},"PeriodicalIF":1.7,"publicationDate":"2025-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145452393","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-11-01DOI: 10.12968/jowc.2025.34.S11c.S55
Karen J Bock, Suzie Ehmann, Naomi Dolgoy, Sandi Davis, Brandy McKeown, Justine C Whitaker, Elizabeth Anderson
Background: The original STRIDE algorithm covered lower-limb lymphoedema but not the upper body.
Aims: To update the STRIDE algorithm for compression selection to treat lymphoedema of the upper limb, breast and trunk by achieving consensus on the definitions and importance of its six aspects.
Method: Using a modified Delphi framework, clinical experts in the field ranked agreement and gave open-ended feedback over two rounds of surveys, with a >70% threshold for agreement.
Results: In the first round, participants represented five continents (n=36). Characteristics that met the threshold consensus of >70% agreement were then applied to the STRIDE algorithm, and the second survey was developed. In the second round (n=22), the definitions of all elements of the STRIDE algorithm had at least 70% agreement or strong agreement. Shape and issues were the elements most often considered first in compression selection, while refill was least often considered first in selection.
Conclusions: This Delphi study achieved consensus on the descriptions of the elements of the revised STRIDE algorithm for compression in upper-limb, breast and trunk lymphoedema. The STRIDE algorithm can now be used to make clinical decisions on selecting compression garments for the upper body.
{"title":"Delphi study on the STRIDE algorithm for compression selection in upper-body lymphoedema.","authors":"Karen J Bock, Suzie Ehmann, Naomi Dolgoy, Sandi Davis, Brandy McKeown, Justine C Whitaker, Elizabeth Anderson","doi":"10.12968/jowc.2025.34.S11c.S55","DOIUrl":"10.12968/jowc.2025.34.S11c.S55","url":null,"abstract":"<p><strong>Background: </strong>The original STRIDE algorithm covered lower-limb lymphoedema but not the upper body.</p><p><strong>Aims: </strong>To update the STRIDE algorithm for compression selection to treat lymphoedema of the upper limb, breast and trunk by achieving consensus on the definitions and importance of its six aspects.</p><p><strong>Method: </strong>Using a modified Delphi framework, clinical experts in the field ranked agreement and gave open-ended feedback over two rounds of surveys, with a >70% threshold for agreement.</p><p><strong>Results: </strong>In the first round, participants represented five continents (<i>n</i>=36). Characteristics that met the threshold consensus of >70% agreement were then applied to the STRIDE algorithm, and the second survey was developed. In the second round (<i>n</i>=22), the definitions of all elements of the STRIDE algorithm had at least 70% agreement or strong agreement. Shape and issues were the elements most often considered first in compression selection, while refill was least often considered first in selection.</p><p><strong>Conclusions: </strong>This Delphi study achieved consensus on the descriptions of the elements of the revised STRIDE algorithm for compression in upper-limb, breast and trunk lymphoedema. The STRIDE algorithm can now be used to make clinical decisions on selecting compression garments for the upper body.</p>","PeriodicalId":17590,"journal":{"name":"Journal of wound care","volume":"34 S11c","pages":"S55-S59"},"PeriodicalIF":1.7,"publicationDate":"2025-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145495830","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-11-01DOI: 10.12968/jowc.2025.34.S11c.S49
Suzie Ehmann, Brandy McKeown, Sue Lawrence, Stephanie Moore, Mariam Aldashti, Sandi Davis
This article presents six case studies demonstrating use of the STRIDE algorithm for selecting compression garments for upper-body lymphoedema. STRIDE offers a structured, evidence-informed and individualised approach to assessment and selection. It incorporates patients' multifactorial and evolving needs, as well as textile properties beyond pressure dosage alone to enhance long-term management and overall quality of life.
{"title":"Case studies of the STRIDE algorithm for compression selection in upper-body lymphoedema.","authors":"Suzie Ehmann, Brandy McKeown, Sue Lawrence, Stephanie Moore, Mariam Aldashti, Sandi Davis","doi":"10.12968/jowc.2025.34.S11c.S49","DOIUrl":"10.12968/jowc.2025.34.S11c.S49","url":null,"abstract":"<p><p>This article presents six case studies demonstrating use of the STRIDE algorithm for selecting compression garments for upper-body lymphoedema. STRIDE offers a structured, evidence-informed and individualised approach to assessment and selection. It incorporates patients' multifactorial and evolving needs, as well as textile properties beyond pressure dosage alone to enhance long-term management and overall quality of life.</p>","PeriodicalId":17590,"journal":{"name":"Journal of wound care","volume":"34 S11c","pages":"S49-S54"},"PeriodicalIF":1.7,"publicationDate":"2025-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145495824","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-11-01DOI: 10.12968/jowc.2025.34.S11e.S1
Leticia Vallejo-Carmona
Background: Negative pressure wound therapy (NPWT) has revolutionised the management of complex wounds via mechanisms such as microdeformation, angiogenesis and exudate control. However, its clinical effect has historically only been evaluated by qualitative and visual parameters. This study integrates near-infrared spectroscopy (NIRS) as a biofeedback tool to quantify physiological response to NPWT in real time.
Objective: This study aimed to quantitatively demonstrate the physiological and structural changes induced by an NPWT system in patients with complex wounds, measured using NIRS.
Methods: A prospective real-world observational study was conducted with a cohort of 23 patients with 33 wounds. Structural and physiological parameters were documented before and after NPWT treatment. Random-intercept mixed-effect statistical models and pre-post comparison tests were used to assess clinical and physiological significance.
Results: The data showed a progressive reduction in wound area and volume, accompanied by an increase in tissue oxygen saturation and a sustained decrease in deoxygenated haemoglobin. These findings, objectively quantified through NIRS as a real-time biofeedback tool, highlight the improvement in oxygenation and wound-bed perfusion and support the hypothesis of tissue biomodulation induced by NPWT.
Conclusion: The integration of NIRS redefines the clinical role of NPWT, allowing therapy to be customised based on specific physiological data. This combination represents a new frontier in precision wound medicine. The results of this study provide a foundation for a new generation of clinical decisions in advanced wound management.
{"title":"Structure-guided negative pressure wound therapy (NPWT): personalised tissue biomodulation with an NPWT system in adults and older adults.","authors":"Leticia Vallejo-Carmona","doi":"10.12968/jowc.2025.34.S11e.S1","DOIUrl":"10.12968/jowc.2025.34.S11e.S1","url":null,"abstract":"<p><strong>Background: </strong>Negative pressure wound therapy (NPWT) has revolutionised the management of complex wounds via mechanisms such as microdeformation, angiogenesis and exudate control. However, its clinical effect has historically only been evaluated by qualitative and visual parameters. This study integrates near-infrared spectroscopy (NIRS) as a biofeedback tool to quantify physiological response to NPWT in real time.</p><p><strong>Objective: </strong>This study aimed to quantitatively demonstrate the physiological and structural changes induced by an NPWT system in patients with complex wounds, measured using NIRS.</p><p><strong>Methods: </strong>A prospective real-world observational study was conducted with a cohort of 23 patients with 33 wounds. Structural and physiological parameters were documented before and after NPWT treatment. Random-intercept mixed-effect statistical models and pre-post comparison tests were used to assess clinical and physiological significance.</p><p><strong>Results: </strong>The data showed a progressive reduction in wound area and volume, accompanied by an increase in tissue oxygen saturation and a sustained decrease in deoxygenated haemoglobin. These findings, objectively quantified through NIRS as a real-time biofeedback tool, highlight the improvement in oxygenation and wound-bed perfusion and support the hypothesis of tissue biomodulation induced by NPWT.</p><p><strong>Conclusion: </strong>The integration of NIRS redefines the clinical role of NPWT, allowing therapy to be customised based on specific physiological data. This combination represents a new frontier in precision wound medicine. The results of this study provide a foundation for a new generation of clinical decisions in advanced wound management.</p>","PeriodicalId":17590,"journal":{"name":"Journal of wound care","volume":"34 S11e","pages":"S1-S23"},"PeriodicalIF":1.7,"publicationDate":"2025-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145489166","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-11-01Epub Date: 2025-10-16DOI: 10.12968/jowc.2025.0448
Jason Mendivil, Abby E McMahon, Oludayo Toby Ojelade, Kelly Hobson, Melissa Marballie, Sandry Alvarez, Vivian Adu-Aboagye, Georgia Chiamba, Donovan Gowdie, Willie E Landrum Ii, Ahlam Alzindani, Habeeb Yazdani, Gabriel Petty, Marie-Chantale Simard, Douglas Schmid, Jessica Meadors
Objective: The purpose of this retrospective case series is to describe real-world clinical experience with DermaBind TL or FM, (HealthTech Wound Care, US), a dehydrated full-thickness placental membrane intended for homologous use as a protective wound covering in wounds of various aetiologies that failed to heal with standard of care (SoC).
Method: This retrospective observational, uncontrolled case series collected data from healthcare providers in the US. Eligible cases were patients, ≥18 years of age, with hard-to-heal wounds who received DermaBind TL or FM after having completed a minimum of four weeks of SoC without evidence of wound improvement. Data collected included patient demographics, wound characteristics and wound size.
Results: The cases of 27 patients encompassing 36 wounds were included. The average age of patients included was 72.4 years (range: 37-101 years). The majority of wounds were pressure ulcers (63.9%), followed by diabetic foot ulcers (19.4%) and venous leg ulcers (8.3%). Wound onset was, on average, 29 weeks prior to the first graft application with the placental membrane, and the average wound size was 34cm2. Graft applications occurred weekly, with an average duration of treatment of 6.7 weeks. The observed average percentage surface area reduction across the 36 wounds was 69.1% (range: -17.6-100%). No adverse events were reported by the provider across all patient cases.
Conclusion: These observations describe the clinical use of DermaBind as a wound covering material consistent with its homologous natural protective role. Larger, prospective studies are warranted to further investigate its clinical use. The authors would like to stress that this non-randomised, retrospective uncontrolled case series was used to describe findings, such as number of grafts applied, observed percentage of surface area reduction and graft wasted, and not to demonstrate efficacy.
{"title":"Clinical use of DermaBind TL/FM as a wound covering for hard-to-heal wounds of various aetiologies: a case series.","authors":"Jason Mendivil, Abby E McMahon, Oludayo Toby Ojelade, Kelly Hobson, Melissa Marballie, Sandry Alvarez, Vivian Adu-Aboagye, Georgia Chiamba, Donovan Gowdie, Willie E Landrum Ii, Ahlam Alzindani, Habeeb Yazdani, Gabriel Petty, Marie-Chantale Simard, Douglas Schmid, Jessica Meadors","doi":"10.12968/jowc.2025.0448","DOIUrl":"10.12968/jowc.2025.0448","url":null,"abstract":"<p><strong>Objective: </strong>The purpose of this retrospective case series is to describe real-world clinical experience with DermaBind TL or FM, (HealthTech Wound Care, US), a dehydrated full-thickness placental membrane intended for homologous use as a protective wound covering in wounds of various aetiologies that failed to heal with standard of care (SoC).</p><p><strong>Method: </strong>This retrospective observational, uncontrolled case series collected data from healthcare providers in the US. Eligible cases were patients, ≥18 years of age, with hard-to-heal wounds who received DermaBind TL or FM after having completed a minimum of four weeks of SoC without evidence of wound improvement. Data collected included patient demographics, wound characteristics and wound size.</p><p><strong>Results: </strong>The cases of 27 patients encompassing 36 wounds were included. The average age of patients included was 72.4 years (range: 37-101 years). The majority of wounds were pressure ulcers (63.9%), followed by diabetic foot ulcers (19.4%) and venous leg ulcers (8.3%). Wound onset was, on average, 29 weeks prior to the first graft application with the placental membrane, and the average wound size was 34cm<sup>2</sup>. Graft applications occurred weekly, with an average duration of treatment of 6.7 weeks. The observed average percentage surface area reduction across the 36 wounds was 69.1% (range: -17.6-100%). No adverse events were reported by the provider across all patient cases.</p><p><strong>Conclusion: </strong>These observations describe the clinical use of DermaBind as a wound covering material consistent with its homologous natural protective role. Larger, prospective studies are warranted to further investigate its clinical use. The authors would like to stress that this non-randomised, retrospective uncontrolled case series was used to describe findings, such as number of grafts applied, observed percentage of surface area reduction and graft wasted, and not to demonstrate efficacy.</p>","PeriodicalId":17590,"journal":{"name":"Journal of wound care","volume":"34 Sup11","pages":"S5-S14"},"PeriodicalIF":1.7,"publicationDate":"2025-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145477056","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-11-01DOI: 10.12968/jowc.2025.34.Sup11c.S1
Windy Cole, Raymond Abdo, Brett Chatman, Amy Couch, Daniel Davis, Eric Lullove, Walaya Methodius-Rayford, Lee Rogers, Robert Snyder, Stephanie Wu, Lucian Feraru, Paul Kim, José Luis Lázaro Martínez, James McGuire
{"title":"LIMB PRESERVATION WITH CELLULAR, ACELLULAR AND MATRIX-LIKE PRODUCTS (CAMPS).","authors":"Windy Cole, Raymond Abdo, Brett Chatman, Amy Couch, Daniel Davis, Eric Lullove, Walaya Methodius-Rayford, Lee Rogers, Robert Snyder, Stephanie Wu, Lucian Feraru, Paul Kim, José Luis Lázaro Martínez, James McGuire","doi":"10.12968/jowc.2025.34.Sup11c.S1","DOIUrl":"https://doi.org/10.12968/jowc.2025.34.Sup11c.S1","url":null,"abstract":"","PeriodicalId":17590,"journal":{"name":"Journal of wound care","volume":"34 Sup11c","pages":"S1-S35"},"PeriodicalIF":1.7,"publicationDate":"2025-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145489136","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Dhafer M Kamal, Ebrahim Matar, Aseel Ahmed Husain, Najla Mohammed Alnetaifi, Wafa Fawzi Hasan, Adel Salman Alsayyad
Objective: Lower extremity amputations (LEA) due to severe trauma, diabetes and peripheral artery disease significantly affect patients' quality of life and require comprehensive rehabilitation. Identifying predictors of LEA is crucial for reducing mortality and morbidity.
Method: This retrospective study analysed data from the Bahrain Defense Force Hospital (Kingdom of Bahrain) (2010-2020) on patients who underwent non-traumatic amputations. Statistical analyses were conducted using Statistical Package for the Social Sciences (SPSS, IBM, US), with a Chi-squared test for categorical variables and logistic regression analysis to identify significant predictors.
Results: Among the 426 patients who underwent 800 amputations, 52.8% (n=225) had minor amputations and 47.2% (n=201) had major amputations. Risk factors for major amputation included age (>70 years), sex (female), hypertension, cardiac disease and chronic kidney disease. Major amputations were significantly associated with high mortality rates.
Conclusion: This study describes the characteristics of patients undergoing non-traumatic LEA in the Kingdom of Bahrain and highlights the risk factors for these procedures, emphasising the need for targeted preventive measures and comprehensive management strategies to improve outcomes. Future studies should focus on developing interventions to address these risk factors.
{"title":"Non-traumatic limb amputations in the Kingdom of Bahrain: an 11-year single-centre experience.","authors":"Dhafer M Kamal, Ebrahim Matar, Aseel Ahmed Husain, Najla Mohammed Alnetaifi, Wafa Fawzi Hasan, Adel Salman Alsayyad","doi":"10.12968/jowc.2024.0434","DOIUrl":"https://doi.org/10.12968/jowc.2024.0434","url":null,"abstract":"<p><strong>Objective: </strong>Lower extremity amputations (LEA) due to severe trauma, diabetes and peripheral artery disease significantly affect patients' quality of life and require comprehensive rehabilitation. Identifying predictors of LEA is crucial for reducing mortality and morbidity.</p><p><strong>Method: </strong>This retrospective study analysed data from the Bahrain Defense Force Hospital (Kingdom of Bahrain) (2010-2020) on patients who underwent non-traumatic amputations. Statistical analyses were conducted using Statistical Package for the Social Sciences (SPSS, IBM, US), with a Chi-squared test for categorical variables and logistic regression analysis to identify significant predictors.</p><p><strong>Results: </strong>Among the 426 patients who underwent 800 amputations, 52.8% (n=225) had minor amputations and 47.2% (n=201) had major amputations. Risk factors for major amputation included age (>70 years), sex (female), hypertension, cardiac disease and chronic kidney disease. Major amputations were significantly associated with high mortality rates.</p><p><strong>Conclusion: </strong>This study describes the characteristics of patients undergoing non-traumatic LEA in the Kingdom of Bahrain and highlights the risk factors for these procedures, emphasising the need for targeted preventive measures and comprehensive management strategies to improve outcomes. Future studies should focus on developing interventions to address these risk factors.</p>","PeriodicalId":17590,"journal":{"name":"Journal of wound care","volume":"34 Sup11a","pages":"XXXi-XXXViii"},"PeriodicalIF":1.7,"publicationDate":"2025-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145471358","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-11-01Epub Date: 2025-10-27DOI: 10.12968/jowc.2025.0499
Katherine W Freeland, Matt D Ramirez, Ashley M Wakelee
Objective: To describe real-world outcomes and safety associated with Relese (StimLabs, US), a fenestrated dehydrated complete human placental membrane (dCHPM), as an adjunct to standard of care (SoC) for hard-to-heal (chronic) ulcers.
Method: A retrospective observational audit of adults with ulcers of ≥4 weeks' duration, despite SoC, treated with the dCHPM at three US centres from May 2023 to April 2025. Outcomes were summarised descriptively and included: complete closure rate; time to closure; closure category; percentage area reduction (PAR); and number of applications to closure. Safety outcomes included wound-related adverse events (AEs), amputation and mortality.
Results: A total of 23 patients with 26 ulcers (42% diabetic foot ulcers; 46% neuropathic; 12% other) were included. In the intent-to-treat (ITT) population, 54% of ulcers achieved complete closure; in the per-protocol (PP) population, 78% closed. Median time to closure was 49 days, with a median of 5.5 applications. At week 12, mean PAR was 56% in the ITT population (77% ≥50% PAR) and 86% in the PP population (100% ≥50% PAR). AEs occurred in 30% of patients, most commonly, local infection (26%) and inflammation (13%). In addition, one amputation and two hospitalisations occurred, none of which were considered related to use of the dCHPM. No serious AEs related to the dCHPM were reported.
Conclusion: In this audit, the dCHPM was associated with timely closure and favourable safety outcomes in real-world practice. These descriptive findings may contribute to the growing body of real-world evidence supporting full-thickness placental membranes as adjuncts to SoC in the treatment of hard-to-heal ulcers.
{"title":"Use of Relese in the treatment of hard-to-heal ulcers: a retrospective, multicentre real-world study.","authors":"Katherine W Freeland, Matt D Ramirez, Ashley M Wakelee","doi":"10.12968/jowc.2025.0499","DOIUrl":"10.12968/jowc.2025.0499","url":null,"abstract":"<p><strong>Objective: </strong>To describe real-world outcomes and safety associated with Relese (StimLabs, US), a fenestrated dehydrated complete human placental membrane (dCHPM), as an adjunct to standard of care (SoC) for hard-to-heal (chronic) ulcers.</p><p><strong>Method: </strong>A retrospective observational audit of adults with ulcers of ≥4 weeks' duration, despite SoC, treated with the dCHPM at three US centres from May 2023 to April 2025. Outcomes were summarised descriptively and included: complete closure rate; time to closure; closure category; percentage area reduction (PAR); and number of applications to closure. Safety outcomes included wound-related adverse events (AEs), amputation and mortality.</p><p><strong>Results: </strong>A total of 23 patients with 26 ulcers (42% diabetic foot ulcers; 46% neuropathic; 12% other) were included. In the intent-to-treat (ITT) population, 54% of ulcers achieved complete closure; in the per-protocol (PP) population, 78% closed. Median time to closure was 49 days, with a median of 5.5 applications. At week 12, mean PAR was 56% in the ITT population (77% ≥50% PAR) and 86% in the PP population (100% ≥50% PAR). AEs occurred in 30% of patients, most commonly, local infection (26%) and inflammation (13%). In addition, one amputation and two hospitalisations occurred, none of which were considered related to use of the dCHPM. No serious AEs related to the dCHPM were reported.</p><p><strong>Conclusion: </strong>In this audit, the dCHPM was associated with timely closure and favourable safety outcomes in real-world practice. These descriptive findings may contribute to the growing body of real-world evidence supporting full-thickness placental membranes as adjuncts to SoC in the treatment of hard-to-heal ulcers.</p>","PeriodicalId":17590,"journal":{"name":"Journal of wound care","volume":"34 Sup11","pages":"S32-S40"},"PeriodicalIF":1.7,"publicationDate":"2025-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145477062","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}