Clinical trial NCT06560502: Modified Multi-Platform Trial Assessing Multiple CAMPs and SOC vs SOC Alone in the Treatment of DFU and VLUs
Official 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 DFUs and VLUs.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Diabetic Foot Ulcer
Venous Leg Ulcer
Ulcer Foot
Leg Ulcer
Lead sponsor: Stability Biologics
Sponsor class: INDUSTRY
Collaborators: name: SerenaGroup, Inc.
First posted: 2024-08-19
Enrollment: 324
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study design is a prospective modified dual platform (matriarch) multicenter randomized controlled clinical trial.
Primary purpose: TREATMENT

Brief summary: This is 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: The purpose of this study is 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 initial plan is to evaluate five CAMPs per wound type; however, the modified platform design permits the inclusion of additional CAMPs.

Eligibility criteria: Inclusion Criteria:

* 1. Subjects must be at least 21 years of age or older. 2. Subjects must have a diagnosis of type 1 or 2 Diabetes mellitus. 3. At randomization subjects must have a target ulcer with a minimum surface area of 1.0 cm2 and a maximum surface area of 5.0 cm2 measured post debridement .

  4. The target ulcer must have been present for a minimum of 4 weeks and a maximum of 52 weeks of standard of care, prior to the initial screening visit.

  5. The target ulcer must be located on the foot with at least 50% of the ulcer below the malleolus.

  6. The target ulcer must be 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.

  7. The 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:

  a. ABI between 0.7 and ≤ 1.3; b. TBI ≥ 0.6; c. TCOM ≥ 40 mmHg; d. PVR: biphasic. 8. 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.

  9. Target ulcers located on the plantar aspect of the foot must be offloaded for at least 14 days prior to enrollment.

  10. The potential subject must consent to using the prescribed offloading method for the duration of the study.

  11. The potential subject must agree to attend the weekly study visits required by the protocol.

  12. The potential subject must be willing and able to participate in the informed consent process.

Exclusion Criteria:

1. The potential subject is known to have a life expectancy of \< 6 months.
2. The potential subject's target ulcer is not secondary to diabetes.
3. The target ulcer is infected, requires systemic antibiotic therapy, or there is cellulitis in the surrounding skin.
4. The target ulcer exposes tendon or bone.
5. There is evidence of osteomyelitis complicating the target ulcer.
6. The potential subject is receiving immunosuppressants (including systemic corticosteroids at doses greater than 10 mg of prednisone per day or equivalent) or cytotoxic chemotherapy or is taking medications that the PI believes will interfere with wound healing (e.g., biologics).
7. The potential subject is taking hydroxyurea .
8. The potential subject has applied topical steroids to the ulcer surface within one month of initial screening.
9. The potential subject with a previous partial amputation on the affected foot that results in a deformity that impedes proper offloading of the target ulcer.
10. The potential subject has glycated hemoglobin (HbA1c) greater than or equal to 12% within 3 months of the initial screening visit.
11. The surface area of the target ulcer has reduced in size by more than 20% in the 2 weeks prior to the initial screening visit ("historical" run-in period). MolecuLight Imaging Device is not required for measurements taken during the historical run-in period (e.g., calculating surface area using length X width is acceptable).
12. The surface area measurement of the Target ulcer decreases by 20% or more during the active 2-week screening phase: the 2 weeks from the initial screening visit (SV-1) to the TV-1 visit during which time the potential subject received SOC.
13. The potential subject has an acute Charcot foot, or an inactive Charcot foot, which impedes proper offloading of the target ulcer.
14. Women who are pregnant or considering becoming pregnant within the next 6 months.

Primary outcomes:
measure: Determine the between-arm difference
timeFrame: 1-12 Weeks
Secondary outcomes:
measure: Time to closure
timeFrame: 1-12 Weeks
measure: Percent Area Reduction
timeFrame: 1-12 weeks
measure: Change in pain in target ulcer
timeFrame: 1-12 Weeks
measure: Adverse Events
timeFrame: 1-14 weeks
measure: Determine improvement in Quality of Life - FWS and determine improvement in Quality of Life - wQOL
timeFrame: 1-12 weeks
Other outcomes:
Locations:
city: Circleville
country: United States
facility: Cutting Edge Research
state: Ohio
Study officials:
References: