Modified Platform Trial Evaluating PpLHACM and SOC Versus SOC Alone in the Treatment of Nonhealing DFUs

NCT06600724 | Recruiting

• 1 other identifier: MIMEDX001
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 1

Brief Summary

This study will evaluate two human amnion/chorion membrane (ppLHACM) products and Standard of Care (SOC) versus SOC alone in the closure of nonhealing diabetic foot ulcers (DFUs).

Conditions

Diabetic Foot Ulcer; Diabetic Foot; Foot Ulcer Due to Type 2 Diabetes Mellitus; Foot Ulcer, Diabetic; Foot Ulcer

Keywords

Ulcer; Foot Ulcer; Diabetic Foot Ulcer; Foot

Outcome Measures

Primary Outcomes (1)

• Percentage of target ulcers achieving wound closure

  The percentage of target ulcers achieving complete wound closure in 12 weeks.

  1 - 12 weeks

Secondary Outcomes (4)

• Percent of wound closure area

  1 - 12 weeks

• Adverse Events

  1 - 12 weeks

• Change in Pain in Target Ulcer

  1 - 12 weeks

• Change in Quality of Life

  1 - 12 weeks

Study Arms (3)

Standard of Care

ACTIVE COMPARATOR

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

Other: Standard of Care

EPIEFFECT

EXPERIMENTAL

EPIEFFECT® is a PURION processed lyophilized human placental tissue allograft that includes the amnion layer, intermediate layer, and chorion layer of the amniotic membrane. The product is intended for use as a barrier to provide a protective environment in acute and chronic wounds.

Other: EPIEFFECT

EPIXPRESS

EXPERIMENTAL

EPIXPRESS™ is a PURION processed lyophilized human placental tissue allograft that includes the amnion layer, intermediate layer, and chorion layer of the amniotic membrane. The product is intended for use as a barrier to provide a protective environment in acute and chronic wounds. EPIXPRESS is fenestrated to help facilitate fluid movement and can be used on wounds that produce copious amounts of exudate.

Other: EPIXPRESS

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

EPIEFFECT OTHER

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

EPIEFFECT

EPIXPRESS OTHER

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

EPIXPRESS

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 randomization subjects must have a target ulcer with a minimum surface area of 0.7 cm\^2 and a maximum surface area of 5.0 cm\^2 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 ulcer may not include exposed tendon or 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

• MiMedx Group, Inc.: lead
• SerenaGroup, Inc.: collaborator

Study Sites (1)

SerenaGroup - Monroeville

Monroeville, Pennsylvania, 15146, United States

RECRUITING

MeSH Terms

Conditions

Diabetic Foot; Foot Ulcer; 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; 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

Study Officials

• Thomas Serena, MD

  SerenaGroup, Inc.

  PRINCIPAL INVESTIGATOR

• Dennis McMahon, MD

  MiMedx Group, Inc.

  STUDY DIRECTOR

Central Study Contacts

Brittany Bonafide

CONTACT

888-960-1343; bbonafide@serenagroups.com

Thomas Serena, MD

CONTACT

tserena@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: CAMPAIGN uses a Prospective Modified Platform Multicenter Randomized Controlled Clinical Trial design.

Study Record Dates

• First Submitted: September 16, 2024
• First Posted: September 19, 2024
• Study Start: August 27, 2024
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)