Nonhealing Diabetic Foot Ulcers Treated With Standard of Care (SOC) Alone or Standard of Care and Amnion-Intermediate-Chorion (AIC)

NCT07014176 | Recruiting Phase 4

• 1 other identifier: CELLBIO-2025-001
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 8

Brief Summary

The purpose of this study is to determine how well our dHPT (Dehydrated Human Placental Tissue) Product and Standard of Care work when compared to Standard of Care alone in achieving complete closure of diabetic foot.

Conditions

Diabetic Foot Ulcer

Keywords

DFU; Diabetic Ulcer; Foot Wound; Diabetic Foot Ulcer; Placenta

Outcome Measures

Primary Outcomes (1)

• Percentage of ulcers with complete wound closure

  The percentage of DFU target ulcers achieving complete wound closure. Closure is defined as 100% re-epithelialization of the ulcer surface without detectable exudate.

  1-12 weeks

Secondary Outcomes (5)

• Time to complete closure for ulcer

  1-12 weeks

• Percentage of wound area change for target ulcer

  1-12 weeks

• Changes to pain associated with the target ulcer

  1-12 weeks

• Incidence of Adverse events

  1-12 weeks

• Determine changes in Quality of Life

  1-12 weeks

Other Outcomes (1)

• Percentage of ulcers with complete wound closure for subjects 65 years or older

  1-12 weeks

Study Arms (2)

Standard of Care

ACTIVE COMPARATOR

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.

Procedure: Standard of Care (SOC)

AIC and Standard of Care

EXPERIMENTAL

Participants with a diabetic foot ulcer (DFU) will receive treatment with an Amnion-Intermediate-Chorion (AIC) sheet product, a dehydrated multilayer human placental tissue derived from donated human tissue, and 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.

Other: Amnion-Intermediate-Chorion; Procedure: Standard of Care (SOC)

Interventions

Amnion-Intermediate-Chorion OTHER

Dehydrated human placental multilayer allograft from derived donated human tissue. AIC contains amnion and chorion layers as well as basement membrane and trophoblast.

AIC and Standard of Care

Standard of Care (SOC) PROCEDURE

Standard of care is to establish a clean, healthy wound bed and optimize the wound environment to have the best chance of healing the wound. This is achieved through wound cleansing, debridement, offloading and moisture balance.

AIC and Standard of Care; Standard of Care

Eligibility Criteria

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

You may qualify if:

• Subjects will be eligible to participate in the study if the following conditions exist:
• years of age or older.
• Diagnosis of type 1 or 2 Diabetes mellitus.
• Hemoglobin A1c (HbA1c) level is \< 12% (108 mmol/mol).
• Target ulcer with a surface area at randomization of 0.7 cm2 to 20.0 cm2 measured post debridement.
• Target ulcer present for minimum of 4 weeks prior to screening visit.
• Target ulcer must be located on the foot with at least 50% of the ulcer below the malleolus.
• 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.
• Affected limb must have adequate perfusion confirmed by vascular assessment. Any of the following methods performed within 3 months of the screening visit are acceptable:
• ABI ≥ 0.7 and ≤ 1.3;
• TBI ≥ 0.6;
• TCOM ≥ 40 mmHg;
• PVR: biphasic or triphasic.

You may not qualify if:

• Subject must consent to using the prescribed off-loading method for the duration of the study.
• Subject must agree to attend study visits required by the protocol.
• Subject must be willing and able to participate in the informed consent process.
• Subjects will be excluded from participation in the study if any of the following conditions exist:
• Known life expectancy of \< 6 months.
• Target ulcer is not secondary to diabetes.
• Target ulcer is infected or there is cellulitis in the surrounding skin.
• Evidence of osteomyelitis complicating the target ulcer.
• Infection in the target ulcer or a location that requires systemic antibiotic therapy.
• Receiving immunosuppressants (including systemic corticosteroids at doses greater than 10 mg of Prednisone per day or equivalent) or cytotoxic chemotherapy is excluded.
• Topical application of steroids to the ulcer surface within one month of screening.
• Previous partial amputation on the affected foot if the resulting deformity impedes proper offloading of the target ulcer.
• Surface area of the target ulcer has reduced in size by more than 20% in the 2 weeks prior to 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).
• Mini Nutritional Assessment (MNA) score of less than 17.
• Acute Charcot foot or an inactive Charcot foot that impedes proper offloading of the target ulcer.

Sponsors & Collaborators

• Cellution Biologics: lead

Study Sites (8)

005

Santa Rosa, California, 95403, United States

RECRUITING

001

Jacksonville, Florida, 32216, United States

RECRUITING

003

Chicago, Illinois, 60611, United States

RECRUITING

007

Mooresville, North Carolina, 28117, United States

RECRUITING

002

Rocky Mount, North Carolina, 27804, United States

RECRUITING

008

Allentown, Pennsylvania, 18104, United States

RECRUITING

004

Philadelphia, Pennsylvania, 19146, United States

RECRUITING

006

Hilton Head Island, South Carolina, 29926, United States

ACTIVE NOT RECRUITING

MeSH Terms

Conditions

Diabetic Foot; Foot Injuries

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies; Leg Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Research Director

  Cellution Biologics

  STUDY DIRECTOR

Central Study Contacts

Bryanna Finstein, BS

CONTACT

6035574660; bryanna.f@cellutionbiologics.com

Cellution Research

CONTACT

6035574660; clinical@cellutionbiologics.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2025
• First Posted: June 10, 2025
• Study Start: July 3, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): October 31, 2026
• Last Updated: October 21, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (8)