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This study is designed to evaluate the effectiveness of Tri-Membrane Wrap™, Membrane Wrap™ and Membrane Wrap-Hydro™ compared to the effectiveness of Standard of Care alone though a retrospective data collection.
This is a retrospective multi-center study collecting real world evidence on the use of Tri-Membrane Wrap™, Membrane Wrap™, Membrane Wrap-Hydro™ and Standard of Care alone in subjects with eligible DFUs, VLUs, PUs, and post operative wounds that have not healed with conventional therapy for greater than or equal to 4 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 Amniotic Membrane | De-Identified subject data will be extracted from investigators' medical records for subjects who received Tri-Membrane Wrap™, Membrane Wrap™, Membrane Wrap-Hydro™ plus SOC in subjects with eligible DFUs, VLUs, PUs and post operative wounds |
| |
| Group 2 SOC | De-identified subject data will be extracted from investigators' medical records who were treated with only Standard of Care with eligible DFUs, VLUs, PUs and post operative wounds. Subjects in the SOC may have received hyperbaric or wound vac therapies as part of their treatments. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tri-Membrane Wrap™ | Device | Membrane Wrap™ |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of wound closure by or on week 16 | Wound closure is defined as: Full epithelialization of the wound with the absence of drainage. Epithelialization is defined as a layer of epithelium visible on the wound surface | 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Wound improvement by or on End of Study (EOS) from baseline | Defined by: >60% reduction in area, or >60% reduction in depth, or >75% reduction in volume | 16 weeks |
| Incidence of wound recurrence within the 16-week study period |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects with difficult to heal partial- or full-thickness diabetic foot ulcers (DFU), venous leg ulcers (VLU), pressure ulcers (PU), and post-operative wounds defined as an ulcer that has not healed with conventional therapy for ≥ 4 weeks.
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| Name | Affiliation | Role |
|---|---|---|
| Marshall Medley | Sponsor GmbH | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Athena Specialty Group | Phoenix | Arizona | 85048 | United States | ||
| Revive Advanced Wound Care |
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| Membrane Wrap™ |
| Device |
Membrane Wrap™ |
|
| Membrane Wrap-Hydro™ | Device | Membrane Wrap-Hydro™ |
|
| Standard of Care | Other | Basic care involves debridement, along with local wound care depending on the wound needs. Debridement involves removal of fibrin and devitalized tissue from the base and the borders of the ulcer which is necessary in all treatment plans to reduce the risk of infection and promote healing. |
|
Incidence of wound recurrence within the 16-week study period
| 16 weeks |
| Mean number of wound free days within the 16-week study period | Mean number of wound free days within the 16-week study period | 16 weeks |
| Toms River |
| New Jersey |
| 08755 |
| United States |
| Houston Foot and Ankle Care | Houston | Texas | 77027 | United States |
| Houston Foot Dr | Houston | Texas | 77095 | United States |
| ID | Term |
|---|---|
| D014647 | Varicose Ulcer |
| D017719 | Diabetic Foot |
| D003668 | Pressure Ulcer |
| ID | Term |
|---|---|
| D014648 | Varicose Veins |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D007871 | Leg Ulcer |
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D003925 | Diabetic Angiopathies |
| D016523 | Foot Ulcer |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D003929 | Diabetic Neuropathies |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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