Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU), Venous Leg Ulcer (VLU)
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICETri-Membrane Wrap™
Membrane Wrap™
DEVICEMembrane Wrap™
Membrane Wrap™
DEVICEMembrane Wrap-Hydro™
Membrane Wrap-Hydro™
OTHERStandard of Care
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.
Sponsors
BioLab Holdings
Study design
Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
1. Subject had the presence of diabetic foot ulcers, Venous insufficiency ulcers, pressure ulcers and/or post-operative wounds 2. Subject has retrospectively been treated with Tri-Membrane Wrap™, Membrane Wrap™ and Membrane Wrap-Hydro™ or Subject has retrospectively been treated with Standard of Care only. 3. Subjects should have been treated from January 2022 to present day.
Exclusion criteria
1. Subjects that did not have a wound closure verification appointment. 2. Any subject who received any product other than Tri-Membrane Wrap™, Membrane Wrap™ and Membrane Wrap-Hydro™ during their treatment time.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of wound closure by or on week 16 | 16 weeks | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Wound improvement by or on End of Study (EOS) from baseline | 16 weeks | Defined by: \>60% reduction in area, or \>60% reduction in depth, or \>75% reduction in volume |
| Incidence of wound recurrence within the 16-week study period | 16 weeks | Incidence of wound recurrence within the 16-week study period |
| Mean number of wound free days within the 16-week study period | 16 weeks | Mean number of wound free days within the 16-week study period |
Countries
United States
Contacts
STUDY_CHAIRMarshall Medley
Sponsor GmbH
Outcome results
None listed