Venous Leg Ulcer
Conditions
Brief summary
This study is designed to assess the clinical effectiveness of Membrane Wrap, a human amniotic membrane for the management of difficult to heal partial- or full-thickness venous leg ulcers (VLUs)
Detailed description
Multi-center (up to 20 sites), prospective, randomized trial assess the clinical effectiveness of human amniotic membrane(s) for the management of difficult to heal partial- or full-thickness venous leg ulcers (VLUs). The primary objective is to evaluate the effectiveness of Membrane wrap™ versus Standard of Care (SOC) in subject with eligible venous leg ulcers.
Interventions
DEVICEMembrane Wrap™
Membrane Wrap™
OTHERStandard of Care
SOC treatment will be defined as: 1) debridement of non-viable, necrotic tissue, 2) application of Biologic as the primary, wound covering, 3) application of a dressing over Biologic that maintains moisture balance, 4) application of a Class 3 high compression system, and 5) wrapping with a covering dressing
Sponsors
BioLab Holdings
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
2 parallel groups randomly assigned in a 1:1 fashion
Eligibility
Sex/Gender
ALL
Age
50 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
In order to be eligible to participate in this study, subjects must meet all of the following criteria: 1. Ulcers of venous origin, as determined by clinical signs and symptoms (e.g. hyperpigmentation of the surrounding skin, history of swelling, varicosities, lipodermatosclerosis and/or dermatitis) or other assessments (e.g. venous reflux test). If the subject has multiple on the same leg and/or bilateral ulcers, the largest should be selected. 2. Venous insufficiency ulcers, of at least 1-month duration, which have not adequately responded to conventional ulcer therapy 3. Venous insufficiency ulcers between 2 cm2 and 16 cm2 4. Venous ulcer has not reduced in area ≥40% from baseline measurements during the 2-week screening period 5. Partial- or full-thickness VLU, including ulcers with tissue damage that extends through the epidermis and into the upper epidermis (papillary dermis), or into the deep dermis 6. Subjects are between 50 and 85 years of age. 7. Subject is expected to be available for 12-week follow-up 8. Subject, or their Legally Authorized Representative (LAR), has read, understood, and signed the IRB/IEC approved Informed Consent Form before screening procedures are undertaken. Subjects who meet any of the following criteria will be excluded from participating in this study: 1. Ankle Brachial Index (ABI) of \<0.7 or Toe Brachial Index (TBI) \<0.5 2. Vasculitis, severe rheumatoid arthritis, and other collagen vascular diseases 3. Clinically significant medical conditions which would impair wound healing, as determined by the investigator, including renal, hepatic, hematologic, neurologic or immune disease 4. Signs and symptoms of infection, cellulitis, osteomyelitis 5. Necrotic ulcer beds 6. Subjects receiving hemodialysis or have uncontrolled diabetes: defined as A1C of greater than or equal to 12. An existing A1C value is allowed if completed within 3 months of subject screening. 7. Subjects who are currently receiving or have received at any time within one month prior to entry into the study, corticosteroids (\>15 mg/day), immunosuppressive agents, radiation therapy, or chemotherapy. Anticipated use of the above agents will exclude subjects from entry into the study. 8. Wound unable to be debrided or subject not able to tolerate debridement 9. Subject not willing or able to comply with compression requirements 10. Subjects enrolled in other wound investigational studies within the past three months, or device studies within the past 30 days.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to wound closure by or on week 12. | 12 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 |
| Frequency of wound closure by or on week 12. | 12 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 |
|---|---|---|
| Rate of VLU improvement by or on End of Study (EOS) from baseline | 12 weeks | defined by: * \>60% reduction in area, or * \>60% reduction in depth, or * \>75% reduction in volume Rate of VLU improvement by or on End of Study (EOS) from baseline |
Countries
United States
Contacts
STUDY_CHAIRMarshall Medley
Sponsor GmbH
Outcome results
None listed