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

A Randomized Controlled Multicenter Clinical Trial Evaluating Dehydrated Human Amnion Membrane (dhAM) and Standard of Care Versus Standard of Care Alone in Nonhealing Diabetic Foot Ulcers

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).

Study Overview

• Status: Recruiting
• Conditions: Diabetic Foot; Foot Ulcer; Diabetic Foot Ulcer; Ulcer Foot
• Intervention / Treatment: Other: Standard of Care; Other: Axolotl DualGraft + SOC

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).

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Thomas Serena, MD; Phone Number: 814-688-4000; Email: serena@serenagroups.com
• Study Contact Backup: Name: Bennett M Rogers; Phone Number: 1008 888-960-1343; Email: brogers@serenagroups.com

Study Locations

• United States
  • California
    • Thousand Oaks, California, United States, 91320
      • Recruiting
      • Performance Foot and Ankle Specialists
      • Contact: Dr. Patel; Phone Number: 805-380-3152; Email: info@performancefa.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard of Care; Standard of care will be cleaning, debridement, ulcer moisture balance, and offloading.	Other: 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.
Experimental: Axolotl DualGraft + SOC; Axolotl DualGraft is a dehydrated human amnion membrane.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to closure for the target ulcer	To determine the proportion of ulcers that heal over 12 weeks for dhAM plus SOC versus SOC alone (Time to closure).	1-12 weeks
Percent area reduction	To determine the percent area reduction (PAR) of the ulcer over the 12-week treatment period.	1-12 weeks
Adverse events	To demonstrate a reduction in adverse events in subjects receiving dhAM plus SOC versus SOC alone.	1-12 Weeks
Determine improvement in quality of life using Wound Quality of Life questionnaire	Quality of Life is assessed using the Wound Quality of Life (wQOL) checklist at TV1, TV3, TV7, TV11, and TV12. This assessment will be used to compare patients receiving dhAM + SOC vs SOC.	1-12 weeks
Determine improvement in quality of life using Forgotten Wound Score questionnaire	Quality of life is assessed using the Forgotten Wound Score (FWS) at TV1, TV3, TV7, TV11, and TV12. This assessment will be used to compare patients receiving dhAM + SOC vs SOC.	1-12 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of ulcers that heal in patients 65 years and older	To determine the proportion of ulcers that heal in patients 65 years or older for dhAM plus SOC versus SOC alone.	1-12 weeks
Determine the effect of chronic inhibitory bacterial load (CIBL) on wound closure	To determine the effect of chronic inhibitory bacterial load (CIBL) as assessed by fluorescence imaging on wound closure. Fluorescent imaging will be assessed at TV1, TV4, TV8, and TV12.	1-12 weeks

Collaborators and Investigators

• Sponsor: Axolotl Biologix
• Collaborators: SerenaGroup, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): September 23, 2024
• Primary Completion (Estimated): October 1, 2025
• Study Completion (Estimated): October 1, 2025

Study Registration Dates

• First Submitted: August 5, 2024
• First Submitted That Met QC Criteria: August 8, 2024
• First Posted (Actual): August 13, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 28, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: Vascular Diseases; Diabetes Mellitus; Diabetes Complications; Leg Ulcer; Ulcer; Skin Ulcer; Foot Diseases; Foot Ulcer; Diabetic Foot; Diabetic Neuropathies; Cellular, Acellular, Matrix-like Product (CAMP); Dehydrated Human Amnion Membrane (dhAM); Ulcer leg
• Additional Relevant MeSH Terms: Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Metabolic Diseases; Diabetes Mellitus; Diabetic Angiopathies; Diabetes Complications; Skin Diseases; Skin Ulcer; Water-Electrolyte Imbalance; Leg Ulcer; Diabetic Neuropathies; Foot Diseases; Ulcer; Dehydration; Diabetic Foot; Foot Ulcer
• Other Study ID Numbers: AXOLCAMP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No