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.

NCT06826339 | Recruiting Phase 4

• 1 other identifier: TIGERCAMP
• Study Type: interventional
• Target: 340
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• The between-arm difference in subjects that complete wound closure

  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.

  1-12 Weeks

Secondary Outcomes (4)

• Difference between CAMP plus SOC versus SOC alone in subjects that complete wound closure

  1-12 weeks

• Percent Area Reduction

  1-12 weeks

• VAS

  1-12 Weeks

• Adverse Events

  1-12 weeks

Other Outcomes (4)

• Wound Quality of Life

  1-12 weeks

• Wound Quality of Life

  1-12 weeks

• Age

  1-12 weeks

Study Arms (6)

DFU CAMP 1 + SOC = ACApatch™ + SOC

EXPERIMENTAL

ACApatch™ is a human amniotic membrane tissue allografts derived from human placental tissue.

Other: ACApatch™

DFU CAMP 2 + SOC = caregraFT™ + SOC

EXPERIMENTAL

caregraFT™ is a human amniotic membrane tissue allografts derived from human placental tissue.

Other: caregraFT™

DFU Standard of Care

ACTIVE COMPARATOR

Standard of care will be cleaning, debridement, ulcer moisture balance, and offloading.

Other: Standard of Care

VLU CAMP 1 + SOC = ACApatch™ + SOC

EXPERIMENTAL

ACApatch™ is a human amniotic membrane tissue allografts derived from human placental tissue.

Other: ACApatch™

VLU CAMP 2 + SOC = caregraFT™ + SOC

EXPERIMENTAL

caregraFT™ is a human amniotic membrane tissue allografts derived from human placental tissue.

Other: caregraFT™

VLU Standard of Care

ACTIVE COMPARATOR

Standard of care will be cleaning, debridement, and ulcer moisture balance.

Other: Standard of Care

Interventions

ACApatch™ OTHER

Participants will receive weekly applications of ACApatch™ and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first.

DFU CAMP 1 + SOC = ACApatch™ + SOC; VLU CAMP 1 + SOC = ACApatch™ + SOC

caregraFT™ OTHER

Participants will receive weekly applications of caregraFT™ and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first.

DFU CAMP 2 + SOC = caregraFT™ + SOC; VLU CAMP 2 + SOC = caregraFT™ + SOC

Standard of Care 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 12 weeks, whichever occurs first.

DFU Standard of Care; VLU Standard of Care

Eligibility Criteria

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

You may qualify if:

• 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:
• ABI between 0.7 and ≤ 1.3;
• TBI ≥ 0.6;
• TCOM ≥ 40 mmHg;
• PVR: biphasic.

You may not qualify if:

• 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 potential subject's target ulcer is infected, requires systemic antibiotic therapy, or there is cellulitis in the surrounding skin.
• The potential subject's target ulcer exposes tendon or bone.
• There is evidence of osteomyelitis complicating the potential subject's 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 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 potential subject's target ulcer has reduced in size by more than 20% in the 2 weeks prior to the initial screening visit ("historical" run-in period). EKare 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).
• The surface area measurement of the potential subject's 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.
• The potential subject has an acute Charcot foot, or an inactive Charcot foot, which impedes proper offloading of the target ulcer.

Sponsors & Collaborators

• Tiger Biosciences, LLC.: lead
• SerenaGroup, Inc.: collaborator

Study Sites (1)

Serena Group

Monroeville, Pennsylvania, 15146, United States

RECRUITING

MeSH Terms

Conditions

Varicose Ulcer; Diabetic Foot; Foot Ulcer; Leg Ulcer; Ulcer

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Varicose Veins; Vascular Diseases; Cardiovascular Diseases; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetic Angiopathies; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies; Foot Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Central Study Contacts

Arshdeep Kaur, MS

CONTACT

1-888-665-5005; arshdeep.kaur@sientra.com

Madison Dunn

CONTACT

mdunn@serenagroups.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 7, 2025
• First Posted: February 13, 2025
• Study Start: December 6, 2024
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: February 13, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)