Modified Multi-Platform Trial Assessing Multiple CAMPs and SOC vs SOC Alone in the Treatment of DFU and VLUs

Stability Biologics

Status: Enrolling

Conditions: Venous Leg Ulcer; Leg Ulcer; Diabetic Foot Ulcer; Ulcer Foot

Treatments: Other: Amnio Tri-Core - VLU; Other: AmnioCore - DFU; Other: Standard of Care-VLU; Other: Amniocore Pro +; Other: Standard of Care-DFU; Other: Amnio Quad-Core - DFU; Other: AmnioCore Pro

Study type: Interventional

Funder types: NETWORK; Industry

Identifiers

NCT06560502

STABLECAMP

Details and patient eligibility

About

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.

Full 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.

Enrollment: 324 estimated patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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 .

  2. 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.

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

  4. 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.

  5. 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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324 participants in 7 patient groups

Standard of Care-DFU

Active Comparator group

Description:

Debridement, reduction of bacterial burden, and proper moisture balance using dressings provided by SerenaGroup. Off-loading using the off-loading boot or total contact cast (TCC) provided by SerenaGroup.

Treatment:

Other: Standard of Care-DFU

AmnioCore - DFU

Experimental group

Description:

Dual layer, amniotic membrane allograft.

Treatment:

Other: AmnioCore - DFU

Amnio Quad-Core - DFU

Experimental group

Description:

Four layer, amniotic membrane allograft.

Treatment:

Other: Amnio Quad-Core - DFU

Amniocore Pro + - DFU

Experimental group

Description:

Dual layer, amnion/chorion membrane allograft.

Treatment:

Other: Amniocore Pro +

Standard of Care-VLU

Active Comparator group

Description:

Debridement, reduction of bacterial burden, and proper moisture balance using dressings provided by SerenaGroup. Compression using multilayer compression wraps provided by SerenaGroup.

Treatment:

Other: Standard of Care-VLU

Amnio Tri-Core - VLU

Experimental group

Description:

Three layer, amniotic membrane allograft.

Treatment:

Other: Amnio Tri-Core - VLU

AmnioCore Pro - VLU

Experimental group

Description:

Three layer, amnion/chorion/amnion membrane allograft.

Treatment:

Other: AmnioCore Pro