Recruiting

Dehydrated Amnion Membrane & Standard of Care

Sponsor:

Axolotl Biologix

Code:

NCT06550596

Conditions

Diabetic Foot

Ulcer Foot

Foot Ulcer

Diabetic Foot Ulcer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Standard of Care

Axolotl DualGraft + SOC

Study Details

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

Study ID

NCT06550596

Start date

Sep 23, 2024

Status verified date

Jan, 2025

Completion date

Oct, 2025

Anticipated

Primary completion date

Oct, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.
  • If the subject has two or more ulcers, they must be separated by at least 2 cm. The largest ulcer satisfying the inclusion and exclusion criteria will be designated as the target ulcer.
  • 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.

Exclusion Criteria:

  • 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.

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Standard of Care

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

experimental: Axolotl DualGraft + SOC

Axolotl DualGraft is a dehydrated human amnion membrane.

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.

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.

Primary outcome measure

  • Efficacy of dhAM + SOC vs SOC [ Time Frame: 1-12 Weeks ]

Central Contacts and Locations

Central contacts

Bennett M Rogers

888-960-1343brogers@serenagroups.com

Thomas Serena, MD

814-688-4000serena@serenagroups.com

Locations

Performance Foot and Ankle Specialists

Recruiting

Thousand Oaks, California, United States, 91320

Contacts

Dr. Patel

805-380-3152info@performancefa.com

More Information

Sponsor

Axolotl Biologix

Last update posted

Jan 30, 2025

Last verified

Jan, 2025

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Axolotl Biologix on 2025-01-30.