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

NCT06560502 | Recruiting

• 1 other identifier: STABLECAMP
• Study Type: interventional
• Target: 324
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetic Foot Ulcer; Venous Leg Ulcer; Ulcer Foot; Leg Ulcer

Outcome Measures

Primary Outcomes (1)

• Determine the between-arm difference

  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.

  1-12 Weeks

Secondary Outcomes (5)

• Time to closure

  1-12 Weeks

• Percent Area Reduction

  1-12 weeks

• Change in pain in target ulcer

  1-12 Weeks

• Adverse Events

  1-14 weeks

• Determine improvement in Quality of Life - FWS and determine improvement in Quality of Life - wQOL

  1-12 weeks

Study Arms (7)

Standard of Care-DFU

ACTIVE COMPARATOR

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.

Other: Standard of Care-DFU

AmnioCore - DFU

EXPERIMENTAL

Dual layer, amniotic membrane allograft.

Other: AmnioCore - DFU

Amnio Quad-Core - DFU

EXPERIMENTAL

Four layer, amniotic membrane allograft.

Other: Amnio Quad-Core - DFU

Amniocore Pro + - DFU

EXPERIMENTAL

Dual layer, amnion/chorion membrane allograft.

Other: Amniocore Pro +

Standard of Care-VLU

ACTIVE COMPARATOR

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

Other: Standard of Care-VLU

Amnio Tri-Core - VLU

EXPERIMENTAL

Three layer, amniotic membrane allograft.

Other: Amnio Tri-Core - VLU

AmnioCore Pro - VLU

EXPERIMENTAL

Three layer, amnion/chorion/amnion membrane allograft.

Other: AmnioCore Pro

Interventions

Standard of Care-DFU OTHER

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 13 weeks, whichever occurs first.

Standard of Care-DFU

AmnioCore - DFU OTHER

Participants will receive weekly applications of AmnioCore and Standard of Care until ulcer closure, or a maximum of 13 weeks, whichever occurs first.

AmnioCore - DFU

Amnio Quad-Core - DFU OTHER

Participants will receive weekly applications of Amnio Quad-Core and Standard of Care until ulcer closure, or a maximum of 13 weeks, whichever occurs first.

Amnio Quad-Core - DFU

Standard of Care-VLU OTHER

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 13 weeks, whichever occurs first.

Standard of Care-VLU

Amnio Tri-Core - VLU OTHER

Participants will receive weekly applications of Amnio Tri-Core and Standard of Care until ulcer closure, or a maximum of 13 weeks, whichever occurs first.

Amnio Tri-Core - VLU

Amniocore Pro + OTHER

Participants will receive weekly applications of Amniocore Pro + and Standard of Care until ulcer closure, or a maximum of 13 weeks, whichever occurs first.

Amniocore Pro + - DFU

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• \. 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.
• The potential subject is known to have a life expectancy of \< 6 months.
• The potential subject's target ulcer is not secondary to diabetes.
• The target ulcer is infected, requires systemic antibiotic therapy, or there is cellulitis in the surrounding skin.
• The target ulcer exposes tendon or bone.
• There is evidence of osteomyelitis complicating the target ulcer.
• 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).
• The potential subject is taking hydroxyurea .
• The potential subject has applied topical steroids to the ulcer surface within one month of initial screening.
• 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.
• The potential subject has glycated hemoglobin (HbA1c) greater than or equal to 12% within 3 months of the initial screening visit.
• 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).

Sponsors & Collaborators

• Stability Biologics: lead
• SerenaGroup, Inc.: collaborator

Study Sites (1)

Cutting Edge Research

Circleville, Ohio, 43113, United States

RECRUITING

MeSH Terms

Conditions

Diabetic Foot; Varicose Ulcer; Foot Ulcer; Leg Ulcer

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies; Varicose Veins; Foot Diseases

Central Study Contacts

Bennett M Rogers

CONTACT

888-960-1343; brogers@serenagroups.com

Thomas Serena, MD

CONTACT

814-688-4000; serena@serenagroups.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The study design is a prospective modified dual platform (matriarch) multicenter randomized controlled clinical trial.

Study Record Dates

• First Submitted: August 15, 2024
• First Posted: August 19, 2024
• Study Start: August 1, 2024
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: January 20, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)