DFU, Diabetic Foot, Diabetic Foot Ulcer, Foot Ulcer, Diabetic, Leg Ulcer, Leg Ulcers Venous, Ulcer, Ulcer Foot, Venous Leg Ulcer
Conditions
Brief summary
The purpose of this study is to evaluate the efficacy of human placental membrane products and standard of care versus standard of care alone in the management of nonhealing diabetic foot ulcers and venous leg ulcers.
Detailed description
This study is a multi-center, prospective, randomized controlled clinical study consisting of 650 subjects from up to 30 centers. The subjects are randomized to receive 1 of 4 treatments, either with Tri-Membrane Wrap™ (HPM-1); Membrane Wrap™ (HPM-2); Membrane Wrap-Lite™ (HPM-3); Membrane Wrap-Hydro™ (HPM-4); and SOC. The target ulcers are evaluated weekly by the investigator. The subject is treated once a week, to receive weekly applications of HPM-1 - HPM - 4 + SOC or SOC alone until or up to 12 weeks or until the study ulcer has completely closed (i.e. 100% closure as assessed by the investigator and confirmed 2 weeks later at the closure confirmation visit (CCV). One additional visit per week is optional for both arms, for the purpose of changing only (1) the secondary dressing in the HPM arm or (2) change the standard of care dressing in the control arm. A trial design diagram is found in Figure 3.
Interventions
OTHERStandard of Care DFU
Beginning at the screening visit, participants will receive weekly treatment with standard of care (cleaning, debridement, ulcer moisture balance, and offloading) until ulcer closure, or a maximum of 12 weeks, whichever occurs first.
Participants will receive weekly applications of Tri-Membrane Wrap™ and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first.
OTHERMembrane Wrap™ DFU
Participants will receive weekly applications of Membrane Wrap™ and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first.
Participants will receive weekly applications of Membrane Wrap-Lite™ and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first.
Participants will receive weekly applications of Membrane Wrap-Hydro™ and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first.
OTHERStandard of Care VLU
Beginning at the screening visit, participants will receive weekly treatment with standard of care (cleaning, debridement, ulcer moisture balance, and compression) until ulcer closure, or a maximum of 12 weeks, whichever occurs first.
Participants will receive weekly applications of Tri-Membrane Wrap™ and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first.
OTHERMembrane Wrap™ VLU
Participants will receive weekly applications of Membrane Wrap™ and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first.
Participants will receive weekly applications of Membrane Wrap-Lite™ and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first.
Participants will receive weekly applications of Membrane Wrap-Hydro™ and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first.
Sponsors
SerenaGroup, Inc.
BioLab Holdings
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This study is a multi-center, prospective, randomized controlled clinical study consisting of 650 subjects from up to 30 centers. The subjects are randomized to receive 1 of 4 treatments, either with Tri-Membrane Wrap™ (HPM-1); Membrane Wrap™ (HPM-2); Membrane Wrap-Lite™ (HPM-3); Membrane Wrap-Hydro™ (HPM-4); and SOC. The target ulcers are evaluated weekly by the investigator.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* The potential subject must be at least 18 years of age or older. * The potential subject must have a diagnosis of type 1 or 2 Diabetes mellitus. * At enrollment, the potential subject must have a target ulcer with a minimum surface area of 1.0 cm2 and a maximum surface area of 20 cm2 measured post debridement with the eKare inSight® imaging device. * The potential subject must have a target ulcer that has been present for a minimum of 4 weeks of standard of care, prior to the initial screening visit. * The potential subject must have a target ulcer located on the foot with at least 50% of the ulcer below the malleolus. * The potential subject must have a target ulcer that is Wagner 1 or 2 grade, extending at least through the dermis or subcutaneous tissue and may involve the muscle provided it is below the medial aspect of the malleolus. The ulcer may not include exposed tendon or bone. * The potential subject's affected limb must have adequate perfusion confirmed by vascular assessment. Any of the following methods performed within 3 months of the first screening visit are acceptable: 1. ABI between 0.7 and ≤ 1.3; 2. TBI ≥ 0.6; 3. TCOM ≥ 40 mmHg; 4. PVR: biphasic. * If the potential subject has two or more ulcers, they must be separated by at least 2 cm. The largest ulcer satisfying the inclusion and
Exclusion criteria
will be designated as the target ulcer. * The potential subject must consent to using the prescribed offloading method for the duration of the study. * The potential subject must agree to attend the weekly study visits required by the protocol. * The potential subject must be willing and able to participate in the informed consent process.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Determine the between-arm difference percentage of subjects achieving complete closure of target ulcer over 12 weeks. | 1-12 Weeks | To determine the between-arm difference of multiple Human Placental Membrane (HPM) products plus SOC versus SOC alone in achieving complete closure of nonhealing diabetic foot ulcers and venous leg ulcers over 12 weeks using a modified dual platform (Matriarch) trial design. The initial plan is to evaluate several HPM per wound type; however, the modified platform design permits the inclusion of additional placental and umbilical cord derived products and can continue in perpetuity. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent Area Reduction (PAR) | 1-12 weeks | To determine the between-arm difference in the percent area reduction (PAR) at weekly intervals for HPM plus SOC versus SOC alone. |
| Determine improvement in quality of life | 1-12 Weeks | To determine the between-arm difference in the quality of life for subjects receiving HPM plus SOC compared to SOC alone using the Wound Quality of Life (wQOL) questionnaire. Scores on a scare from Not at all to Very much. |
| Time to Closure | 1-12 weeks | To determine the between-arm difference in the time to closure over 12 weeks for HPM plus SOC versus SOC alone. |
| Proportion of patients that reach complete closure over 65 | 1-12 weeks | To determine the proportion of ulcers that heal in patients 65 years or older for HPM plus SOC versus SOC alone. |
| Functional Ambulatory Category Scale | 1-12 Weeks | To evaluate the between-arm difference in functional ambulation based on Functional Ambulatory Category Scale (FACS) - VLU subjects only. FACS is a scale from 0-5, 5 being completely independent and ambulatory on all surfaces. |
| Pain in patients who present with VAS greater than 4 | 1-12 weeks | To determine the between-arm difference in pain for patients that present with a Visual Analog Sale (VAS) score of greater than 4. The VAS has a scale of 0-10. 0 Meaning no pain and 10 being the worst pain. |
Countries
United States
Contacts
Primary ContactBennett Sarver
Backup ContactThomas Serena
Outcome results
None listed