Diabetic Foot, Diabetic Foot Ulcer, Foot Ulcer, Diabetic, Leg Ulcer, Ulcer, Ulcer Foot, Ulcer Venous, Venous Leg, Venous Leg Ulcer
Conditions
Brief summary
Title A Multicenter, Prospective, Randomized Controlled Modified Multi-Platform (Matriarch) Trial Evaluating Several Cellular, Acellular, and Matrix-like Products (CAMPs) and Standard of Care versus Standard of Care alone in the Management of Nonhealing Diabetic Foot and Venous Leg Ulcers.
Detailed description
To determine the between-arm difference in the proportion of subjects achieving complete closure of nonhealing diabetic foot ulcers and venous leg ulcers with multiple CAMPs plus SOC versus SOC alone over 12 weeks using a modified dual platform (Matriarch) trial design.
Interventions
OTHERACApatch™
Participants will receive weekly applications of ACApatch™ and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first.
OTHERcaregraFT™
Participants will receive weekly applications of caregraFT™ and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first.
OTHERStandard of Care
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.
Sponsors
SerenaGroup, Inc.
Tiger Biosciences, LLC.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
For a platform trial design, the allocation ratio is equal to the square root of the number of Intervention groups. This study will include 4 Intervention groups and 2 Control groups. A treatment effect of 0.35, significance level of 5%, 80% power, and a 1.4:1:1 for the VLU platform and 1.4:1:1 ratio for the DFU platform.
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
(DFU) * Subjects The potential subject must be at least 21 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 20.0 cm2 measured post debridement. * The potential subject must have a target ulcer that has been present for a minimum of 4 weeks and a maximum of 52 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 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 post-debridement. The largest ulcer satisfying the inclusion and
Exclusion criteria
will be designated as the target ulcer. The potential subject must have a target ulcers located on the plantar aspect of the foot must be offloaded for at least 14 days prior to enrollment. * 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 |
|---|---|---|
| The between-arm difference in subjects that complete wound closure | 1-12 Weeks | To determine the between-arm difference in the proportion of subjects achieving complete closure of nonhealing diabetic foot ulcers and venous leg ulcers with multiple CAMPs plus SOC versus SOC alone over 12 weeks using a modified dual platform (Matriarch) trial design. The platform design permits the inclusion of additional products by amending the protocol. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent Area Reduction | 1-12 weeks | To determine the between-arm difference in the percent area reduction (PAR) at weekly intervals the CAMP plus SOC arms versus SOC alone. |
| Difference between CAMP plus SOC versus SOC alone in subjects that complete wound closure | 1-12 weeks | To determine the between-arm difference in the time to closure over 12 weeks for CAMP plus SOC versus SOC alone. |
| VAS | 1-12 Weeks | To determine the between-arm difference in pain for patients that present with a VAS score of greater than 4. |
| Adverse Events | 1-12 weeks | To evaluate the between-arm difference in the frequency and nature of adverse events in subjects receiving CAMP plus SOC versus SOC alone. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Functional Ambulatory Category Scale | 1-12 weeks | 3\. To evaluate the between-arm difference in functional ambulation based on Functional Ambulatory Category Scale (FACS) - VLU subjects only. |
| Age | 1-12 weeks | To determine the proportion of ulcers that close in patients 65 years or older for CAMP plus SOC versus SOC alone. |
| Wound Quality of Life | 1-12 weeks | To evaluate the between-arm difference in the quality of life for subjects receiving CAMP plus SOC compared to SOC alone using the Forgotten Wound Score (FWS) at treatment visits 1, 4, 8, and 12. |
Countries
United States
Contacts
Primary ContactArshdeep Kaur, MS
Backup ContactMadison Dunn
Outcome results
None listed