Modified Platform Trial Assessing Multiple CAMPs and SOC vs SOC Alone in the Treatment of Hard-to-Heal DFUs

NCT06449638 | Recruiting

• 1 other identifier: HPM2401.001-M (07/24)
• Study Type: interventional
• Target: 272
• Locations: 1 country
• Sites: 5

Brief Summary

The purpose of this study is to evaluate the efficacy of four dehydrated complete human placental membrane, also defined as Cellular, Acellular, Matrix-like Products/skin substitutes, plus SOC versus SOC alone in achieving complete closure of hard-to-heal diabetic foot ulcers over 12 weeks using a modified platform trial design.

Conditions

Diabetic Foot Ulcer (DFU); Ulcer Foot; Diabetic Foot; Foot Ulcer

Keywords

Cellular, Acellular, Matrix-like Product (CAMP); Cellular and/or Tissue Product (CTP); Dehydrated Complete Human Placental Membrane (dCHPM)

Outcome Measures

Primary Outcomes (1)

• The percentage of target ulcers achieving complete wound closure

  Determine the percent of target ulcers achieving complete wound closure at 12 weeks. In addition, a qualified third-party clinician will independently confirm wound closure.

  1-12 weeks

Secondary Outcomes (6)

• Time to closure for the target ulcer

  1-12 weeks

• Percent area reduction

  1-12 weeks

• Adverse events

  1-14 weeks

• Change in pain in target ulcer

  1-14 weeks

• Determine improvement in Quality of Life - wQOL

  12 weeks

Study Arms (5)

Standard of Care

ACTIVE COMPARATOR

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

Other: Standard of Care

Revita

EXPERIMENTAL

Revita is an opaque, lyophilized dehydrated complete human placental membrane (dCHPM) allograft.

Other: Revita

Relese

EXPERIMENTAL

Relese is a fenestrated dehydrated complete human placental membrane (dCHPM) allograft.

Other: Relese

Cogenex

EXPERIMENTAL

Cognenex is a fenestrated dehydrated complete human placental membrane (dCHPM) allograft.

Other: Cogenex

Enverse

EXPERIMENTAL

Enverse is a translucent dehydrated complete human placental membrane (dCHPM) allograft.

Other: Enverse

Interventions

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.

Standard of Care

Revita OTHER

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

Revita

Relese OTHER

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

Relese

Cogenex OTHER

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

Cogenex

Enverse OTHER

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

Enverse

Eligibility Criteria

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

You may qualify if:

• At least 18 years of age or older.
• Diagnosis of type 1 or 2 Diabetes mellitus.
• At enrollment, target ulcer with a minimum surface area of 1.0 cm2 and a maximum surface area of 25.0 cm2 measured post debridement with the MolecuLight® Imaging Device.
• 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 full thickness without exposed bone.
• 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:
• Ankle-Brachial Index (ABI) between 0.7 and ≤ 1.3;
• Toe-Brachial Index (TBI) ≥ 0.6;
• Transcutaneous Oxygen Measurement (TCOM) ≥ 40 mmHg;
• Pulse Volume Resistance (PVR): biphasic.

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 or there is cellulitis in the surrounding skin.
• The target ulcer exposes tendon or bone.
• There is evidence of osteomyelitis complicating the target ulcer.
• There is an infection in the target ulcer or in a remote location that requires systemic antibiotic therapy.
• 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.

Sponsors & Collaborators

• StimLabs: lead
• SerenaGroup, Inc.: collaborator

Study Sites (5)

SerenaGroup Omaha Research Center

Omaha, Nebraska, 68114, United States

RECRUITING

Wound Care of Tulsa

Tulsa, Oklahoma, 74135, United States

RECRUITING

SerenaGroup Research South

Jefferson Hills, Pennsylvania, 15025, United States

NOT YET RECRUITING

Armstrong County Memorial Hospital

Kittanning, Pennsylvania, 16201, United States

NOT YET RECRUITING

SerenaGroup Monroeville

Monroeville, Pennsylvania, 15146, United States

RECRUITING

MeSH Terms

Conditions

Diabetic Foot; Foot Ulcer

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

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

Central Study Contacts

Kristy Breisinger

CONTACT

888-960-1343; kbreisinger@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: CAMPSTIM employs a novel modified platform clinical trial design. CAMPSTIM will evaluate several CAMPs, specifically (4) placental-based CAMPs and Standard of Care (SOC) versus SOC alone in the treatment of nonhealing diabetic foot ulcers. The initial plan is to evaluate the four CAMPs identified in this protocol; however, the platform design allows for the inclusion of additional products which will be added following an interval analysis.

Study Record Dates

• First Submitted: May 28, 2024
• First Posted: June 10, 2024
• Study Start: July 16, 2024
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 2, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)