Dehydrated Human Amnion Membrane and Standard of Care Versus Standard of Care Alone in Nonhealing Diabetic Foot Ulcers

NCT ID: NCT06550596

Last Updated: 2025-01-30

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-23
• Study Completion Date: 2025-10-31

Brief Summary

The purpose of this study is to evaluate the efficacy of dehydrated human amnion membrane (dhAM) and standard of care (SOC) versus SOC alone in the closure of nonhealing diabetic foot ulcers (DFUs).

Detailed Description

AXOCAMP is a multi-center randomized controlled clinical trial. The study will evaluate the efficacy of dehydrated human amnion membrane (dhAM) and standard of care (SOC) versus SOC alone in the closure of nonhealing diabetic foot ulcers (DFUs).

Conditions

Diabetic Foot; Ulcer Foot; Foot Ulcer; Diabetic Foot Ulcer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Standard of Care

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

Group Type: ACTIVE_COMPARATOR

Standard of Care

Intervention Type: 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.

Axolotl DualGraft + SOC

Axolotl DualGraft is a dehydrated human amnion membrane.

Group Type: EXPERIMENTAL

Axolotl DualGraft + SOC

Intervention Type: OTHER

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

Interventions

Standard of Care

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.

Intervention Type: OTHER

Axolotl DualGraft + SOC

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Subjects must be at least 18 years of age or older.
• Subjects must have a diagnosis of type 1 or 2 Diabetes mellitus.
• 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 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:

1. ABI ≥ 0.7 and ≤ 1.3;

2. TBI ≥ 0.6;

3. TCOM ≥ 40 mmHg;

4. PVR: biphasic.

Exclusion Criteria

• The subject must consent to using the prescribed offloading method for the duration of the study.
• The subject must agree to attend the weekly study visits required by the protocol.
• The subject must be willing and able to participate in the informed consent process.

• A subject known to have a life expectancy of < 6 months is excluded.
• The subject is excluded if the target ulcer is not secondary to diabetes.
• If the target ulcer is infected or if there is cellulitis in the surrounding skin, the subject is excluded.
• If there is evidence of osteomyelitis complicating the target ulcer, the subject is excluded.
• A potential subject cannot have an infection in the target ulcer or in a remote location that requires systemic antibiotic therapy.
• A subject receiving immunosuppressants (including systemic corticosteroids at doses greater than 10 mg of Prednisone per day or equivalent) or cytotoxic chemotherapy is excluded.
• The topical application of steroids to the ulcer surface within one month of initial screening is not permitted.
• A subject with a previous partial amputation on the affected foot is excluded if the resulting deformity impedes proper offloading of the target ulcer.
• The subject is excluded if 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). Photographic planimetry is not required for measurements taken during the historical run-in period (e.g. calculating surface area using length x width is acceptable).
• The subject is excluded if the surface area measurement of the Target ulcer decreases by 20% or more during the 2-week screening phase: the 2 weeks from the initial screening visit (S1) to the TV-1/randomization visit, during which time the subject received SOC.
• A subject is excluded if they are malnourished: a score of less than 17 on the Mini Nutritional Assessment (MNA).
• A Subject with an acute Charcot foot, or an inactive Charcot foot, that impedes proper offloading of the target ulcer is excluded.
• Women who are pregnant or considering becoming pregnant within the next 6 months are excluded.
• A potential subject with end stage renal disease requiring dialysis is excluded.
• A subject who, in the opinion of the investigator, has a medical or psychological condition that may interfere with study assessments is excluded.
• A Subject treated with hyperbaric oxygen therapy or a Cellular Acellular, or Matrix-like Product (CAMP) in the 30 days prior to the initial screening visit is excluded.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

SerenaGroup, Inc.

NETWORK

Sponsor Role: collaborator

Axolotl Biologix

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Performance Foot and Ankle Specialists

Thousand Oaks, California, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Bennett M Rogers

Role: CONTACT

brogers@serenagroups.com

888-960-1343 ext. 1008

Thomas Serena, MD

Role: CONTACT

serena@serenagroups.com

814-688-4000

Facility Contacts

Dr. Patel

Role: primary

info@performancefa.com

805-380-3152

Other Identifiers

AXOLCAMP

Identifier Type: -

Identifier Source: org_study_id