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

NCT06550596 | Recruiting

• 1 other identifier: AXOLCAMP
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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).

Conditions

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

Keywords

Cellular, Acellular, Matrix-like Product (CAMP); Dehydrated Human Amnion Membrane (dhAM); Vascular Diseases; Leg Ulcer; Ulcer leg; Skin Ulcer; Diabetes Complications; Diabetes Mellitus; Diabetic Neuropathies; Foot Diseases; Diabetic Foot; Foot Ulcer; Ulcer

Outcome Measures

Primary Outcomes (1)

• Efficacy of dhAM + SOC vs SOC

  To determine the efficacy of dhAM plus SOC versus SOC alone in achieving complete closure of nonhealing diabetic foot ulcers over 12 weeks.

  1-12 Weeks

Secondary Outcomes (5)

• Time to closure for the target ulcer

  1-12 weeks

• Percent area reduction

  1-12 weeks

• Adverse events

  1-12 Weeks

• Determine improvement in quality of life using Wound Quality of Life questionnaire

  1-12 weeks

• Determine improvement in quality of life using Forgotten Wound Score questionnaire

  1-12 weeks

Other Outcomes (2)

• Proportion of ulcers that heal in patients 65 years and older

  1-12 weeks

• Determine the effect of chronic inhibitory bacterial load (CIBL) on wound closure

  1-12 weeks

Study Arms (2)

Standard of Care

ACTIVE COMPARATOR

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

Other: Standard of Care

Axolotl DualGraft + SOC

EXPERIMENTAL

Axolotl DualGraft is a dehydrated human amnion membrane.

Other: Axolotl DualGraft + SOC

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

Axolotl DualGraft + SOC 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.

Axolotl DualGraft + SOC

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Axolotl Biologix: lead
• SerenaGroup, Inc.: collaborator

Study Sites (1)

Performance Foot and Ankle Specialists

Thousand Oaks, California, 91320, United States

RECRUITING

MeSH Terms

Conditions

Diabetic Foot; Foot Ulcer; Vascular Diseases; Leg Ulcer; Skin Ulcer; Diabetes Complications; Diabetes Mellitus; Diabetic Neuropathies; Foot Diseases; Ulcer

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Cardiovascular Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Endocrine System Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Musculoskeletal 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

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: AXOLCAMP is a multi-center, open label, randomized controlled trial to determine the efficacy of dhAM plus SOC versus SOC alone in achieving complete closure of nonhealing diabetic foot ulcers. over 12 weeks.

Study Record Dates

• First Submitted: August 5, 2024
• First Posted: August 13, 2024
• Study Start: September 23, 2024
• Primary Completion: October 1, 2025
• Study Completion: October 1, 2025
• Last Updated: January 30, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)