A Multicenter, Randomized, Controlled, Clinical Trial Evaluating a Lyopreserved Amniotic Membrane in the Treatment of Venous Leg Ulcers
ABSTRACT Background Standard of Care (SoC) with multilayer compression therapy along with proper wound management, may not be sufficient to close all venous ulcers and needs advanced therapies. Methods In this multicenter, prospective, randomized, controlled, open‐label trial, 351 patients were scre...
Saved in:
| Main Authors: | , , , , , , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
Wiley
2025-05-01
|
| Series: | Health Science Reports |
| Subjects: | |
| Online Access: | https://doi.org/10.1002/hsr2.70819 |
| Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
| _version_ | 1849243101800955904 |
|---|---|
| author | Yadwinder Dhillon Lena Levine Gregory Tovmassian Alexander Reyzelman Francisco Perez‐Clavijo Francis Wodie Shawn Cazzell Allan Grossman Lesly Robinson Felix Sigal Robert S Kirsner Mher Vartivarian Molly Saunders Jaideep Banerjee |
| author_facet | Yadwinder Dhillon Lena Levine Gregory Tovmassian Alexander Reyzelman Francisco Perez‐Clavijo Francis Wodie Shawn Cazzell Allan Grossman Lesly Robinson Felix Sigal Robert S Kirsner Mher Vartivarian Molly Saunders Jaideep Banerjee |
| author_sort | Yadwinder Dhillon |
| collection | DOAJ |
| description | ABSTRACT Background Standard of Care (SoC) with multilayer compression therapy along with proper wound management, may not be sufficient to close all venous ulcers and needs advanced therapies. Methods In this multicenter, prospective, randomized, controlled, open‐label trial, 351 patients were screened, 200 were eligible and enrolled and were randomized 1:1 to LPM (lyopreserved cellular placental membrane) plus SoC or SoC alone for up to 12 weeks. Patients were enrolled between June 2018 and November 2020 at 30 sites across the United States. Outcome measures included complete closure of the index ulcer (primary), reduction in wound size, rate of closure, quality of life, and adverse events. Results ITT analysis revealed that wounds treated with weekly applications of LPM as an adjunct to standard of care, reduced in size significantly more than SoC alone, at the end of 4, 8, and 12 graft applications, indicating a faster progression to closure. There was a statistically 1.72 higher relative risk or 72% higher probability of wound closure with LPM compared to the SoC group during the study period for wounds with an initial size of 3–25 cm2. Use of LPM as an adjunct was able to close statistically larger‐sized wounds on average. There was also a statistically significant fivefold improvement in quality of life (overall physical symptoms and daily life) over baseline, in the LPM treated patients as compared to the control group. Conclusion LPM and standard of care, significantly closed more venous leg ulcers and faster than standard of care alone and improved the quality of life for patients, suggesting that the use of aseptically processed LPM is a safe and effective treatment option in the healing of chronic venous leg ulcers. Trial Registration: ClinicalTrials.gov ID: NCT03629236, Study to Evaluate Safety and Efficacy of GrafixPL for the Treatment of Venous Leg Ulcers. (https://clinicaltrials.gov/study/NCT03629236). |
| format | Article |
| id | doaj-art-1033fabfdc6f4831b141c2bc6048870a |
| institution | Kabale University |
| issn | 2398-8835 |
| language | English |
| publishDate | 2025-05-01 |
| publisher | Wiley |
| record_format | Article |
| series | Health Science Reports |
| spelling | doaj-art-1033fabfdc6f4831b141c2bc6048870a2025-08-20T03:59:36ZengWileyHealth Science Reports2398-88352025-05-0185n/an/a10.1002/hsr2.70819A Multicenter, Randomized, Controlled, Clinical Trial Evaluating a Lyopreserved Amniotic Membrane in the Treatment of Venous Leg UlcersYadwinder Dhillon0Lena Levine1Gregory Tovmassian2Alexander Reyzelman3Francisco Perez‐Clavijo4Francis Wodie5Shawn Cazzell6Allan Grossman7Lesly Robinson8Felix Sigal9Robert S Kirsner10Mher Vartivarian11Molly Saunders12Jaideep Banerjee13Titan Clinical Solutions Phoenix Arizona USAAcclaim Bone & Joint Institute Fort Worth Texas USACenter for Clinical Research Carmichael California USACenter for Clinical Research Castro Valley California USAIntegral Clinical Trials Solutions Doral Florida USAIntegral Clinical Trials Solutions Homestead Florida USALimb Preservation Platform Fresno California USAHarrisburg Foot and Ankle Center Harrisburg Pennsylvania USATemple University School of Podiatric Medicine Philadelphia Pennsylvania USALA Foot Pain and Ankle Clinic Los Angeles California USAUniversity of Miami Miami Florida USACenter for Clinical Research San Francisco California USAOsiris Therapeutics Columbia Maryland USASmith & Nephew Inc. Fortworth Texas USAABSTRACT Background Standard of Care (SoC) with multilayer compression therapy along with proper wound management, may not be sufficient to close all venous ulcers and needs advanced therapies. Methods In this multicenter, prospective, randomized, controlled, open‐label trial, 351 patients were screened, 200 were eligible and enrolled and were randomized 1:1 to LPM (lyopreserved cellular placental membrane) plus SoC or SoC alone for up to 12 weeks. Patients were enrolled between June 2018 and November 2020 at 30 sites across the United States. Outcome measures included complete closure of the index ulcer (primary), reduction in wound size, rate of closure, quality of life, and adverse events. Results ITT analysis revealed that wounds treated with weekly applications of LPM as an adjunct to standard of care, reduced in size significantly more than SoC alone, at the end of 4, 8, and 12 graft applications, indicating a faster progression to closure. There was a statistically 1.72 higher relative risk or 72% higher probability of wound closure with LPM compared to the SoC group during the study period for wounds with an initial size of 3–25 cm2. Use of LPM as an adjunct was able to close statistically larger‐sized wounds on average. There was also a statistically significant fivefold improvement in quality of life (overall physical symptoms and daily life) over baseline, in the LPM treated patients as compared to the control group. Conclusion LPM and standard of care, significantly closed more venous leg ulcers and faster than standard of care alone and improved the quality of life for patients, suggesting that the use of aseptically processed LPM is a safe and effective treatment option in the healing of chronic venous leg ulcers. Trial Registration: ClinicalTrials.gov ID: NCT03629236, Study to Evaluate Safety and Efficacy of GrafixPL for the Treatment of Venous Leg Ulcers. (https://clinicaltrials.gov/study/NCT03629236).https://doi.org/10.1002/hsr2.70819allograftsamniotic membranequality of lifeskin substitutevenous ulcers |
| spellingShingle | Yadwinder Dhillon Lena Levine Gregory Tovmassian Alexander Reyzelman Francisco Perez‐Clavijo Francis Wodie Shawn Cazzell Allan Grossman Lesly Robinson Felix Sigal Robert S Kirsner Mher Vartivarian Molly Saunders Jaideep Banerjee A Multicenter, Randomized, Controlled, Clinical Trial Evaluating a Lyopreserved Amniotic Membrane in the Treatment of Venous Leg Ulcers Health Science Reports allografts amniotic membrane quality of life skin substitute venous ulcers |
| title | A Multicenter, Randomized, Controlled, Clinical Trial Evaluating a Lyopreserved Amniotic Membrane in the Treatment of Venous Leg Ulcers |
| title_full | A Multicenter, Randomized, Controlled, Clinical Trial Evaluating a Lyopreserved Amniotic Membrane in the Treatment of Venous Leg Ulcers |
| title_fullStr | A Multicenter, Randomized, Controlled, Clinical Trial Evaluating a Lyopreserved Amniotic Membrane in the Treatment of Venous Leg Ulcers |
| title_full_unstemmed | A Multicenter, Randomized, Controlled, Clinical Trial Evaluating a Lyopreserved Amniotic Membrane in the Treatment of Venous Leg Ulcers |
| title_short | A Multicenter, Randomized, Controlled, Clinical Trial Evaluating a Lyopreserved Amniotic Membrane in the Treatment of Venous Leg Ulcers |
| title_sort | multicenter randomized controlled clinical trial evaluating a lyopreserved amniotic membrane in the treatment of venous leg ulcers |
| topic | allografts amniotic membrane quality of life skin substitute venous ulcers |
| url | https://doi.org/10.1002/hsr2.70819 |
| work_keys_str_mv | AT yadwinderdhillon amulticenterrandomizedcontrolledclinicaltrialevaluatingalyopreservedamnioticmembraneinthetreatmentofvenouslegulcers AT lenalevine amulticenterrandomizedcontrolledclinicaltrialevaluatingalyopreservedamnioticmembraneinthetreatmentofvenouslegulcers AT gregorytovmassian amulticenterrandomizedcontrolledclinicaltrialevaluatingalyopreservedamnioticmembraneinthetreatmentofvenouslegulcers AT alexanderreyzelman amulticenterrandomizedcontrolledclinicaltrialevaluatingalyopreservedamnioticmembraneinthetreatmentofvenouslegulcers AT franciscoperezclavijo amulticenterrandomizedcontrolledclinicaltrialevaluatingalyopreservedamnioticmembraneinthetreatmentofvenouslegulcers AT franciswodie amulticenterrandomizedcontrolledclinicaltrialevaluatingalyopreservedamnioticmembraneinthetreatmentofvenouslegulcers AT shawncazzell amulticenterrandomizedcontrolledclinicaltrialevaluatingalyopreservedamnioticmembraneinthetreatmentofvenouslegulcers AT allangrossman amulticenterrandomizedcontrolledclinicaltrialevaluatingalyopreservedamnioticmembraneinthetreatmentofvenouslegulcers AT leslyrobinson amulticenterrandomizedcontrolledclinicaltrialevaluatingalyopreservedamnioticmembraneinthetreatmentofvenouslegulcers AT felixsigal amulticenterrandomizedcontrolledclinicaltrialevaluatingalyopreservedamnioticmembraneinthetreatmentofvenouslegulcers AT robertskirsner amulticenterrandomizedcontrolledclinicaltrialevaluatingalyopreservedamnioticmembraneinthetreatmentofvenouslegulcers AT mhervartivarian amulticenterrandomizedcontrolledclinicaltrialevaluatingalyopreservedamnioticmembraneinthetreatmentofvenouslegulcers AT mollysaunders amulticenterrandomizedcontrolledclinicaltrialevaluatingalyopreservedamnioticmembraneinthetreatmentofvenouslegulcers AT jaideepbanerjee amulticenterrandomizedcontrolledclinicaltrialevaluatingalyopreservedamnioticmembraneinthetreatmentofvenouslegulcers AT yadwinderdhillon multicenterrandomizedcontrolledclinicaltrialevaluatingalyopreservedamnioticmembraneinthetreatmentofvenouslegulcers AT lenalevine multicenterrandomizedcontrolledclinicaltrialevaluatingalyopreservedamnioticmembraneinthetreatmentofvenouslegulcers AT gregorytovmassian multicenterrandomizedcontrolledclinicaltrialevaluatingalyopreservedamnioticmembraneinthetreatmentofvenouslegulcers AT alexanderreyzelman multicenterrandomizedcontrolledclinicaltrialevaluatingalyopreservedamnioticmembraneinthetreatmentofvenouslegulcers AT franciscoperezclavijo multicenterrandomizedcontrolledclinicaltrialevaluatingalyopreservedamnioticmembraneinthetreatmentofvenouslegulcers AT franciswodie multicenterrandomizedcontrolledclinicaltrialevaluatingalyopreservedamnioticmembraneinthetreatmentofvenouslegulcers AT shawncazzell multicenterrandomizedcontrolledclinicaltrialevaluatingalyopreservedamnioticmembraneinthetreatmentofvenouslegulcers AT allangrossman multicenterrandomizedcontrolledclinicaltrialevaluatingalyopreservedamnioticmembraneinthetreatmentofvenouslegulcers AT leslyrobinson multicenterrandomizedcontrolledclinicaltrialevaluatingalyopreservedamnioticmembraneinthetreatmentofvenouslegulcers AT felixsigal multicenterrandomizedcontrolledclinicaltrialevaluatingalyopreservedamnioticmembraneinthetreatmentofvenouslegulcers AT robertskirsner multicenterrandomizedcontrolledclinicaltrialevaluatingalyopreservedamnioticmembraneinthetreatmentofvenouslegulcers AT mhervartivarian multicenterrandomizedcontrolledclinicaltrialevaluatingalyopreservedamnioticmembraneinthetreatmentofvenouslegulcers AT mollysaunders multicenterrandomizedcontrolledclinicaltrialevaluatingalyopreservedamnioticmembraneinthetreatmentofvenouslegulcers AT jaideepbanerjee multicenterrandomizedcontrolledclinicaltrialevaluatingalyopreservedamnioticmembraneinthetreatmentofvenouslegulcers |