Study Evaluating Several CAMPs in Nonhealing Diabetic Foot and Venous Leg Ulcers

NCT06562296 | Completed Phase 4

• 1 other identifier: CELLBIO-2024-001
• Study Type: interventional
• Target: 292
• Locations: 1 country
• Sites: 4

Brief Summary

The purpose of this study is to determine how well multiple CAMPs (Cellular, Acellular and Matrix-Like Products) and Standard of Care work when compared to Standard of Care alone in achieving complete closure of diabetic foot and venous leg ulcers.

Conditions

Diabetic Foot Ulcer; Venous Leg Ulcer

Keywords

diabetic foot ulcer; venous leg ulcer; DFU; VLU; ulcer

Outcome Measures

Primary Outcomes (1)

• Percentage of ulcers with complete wound closure

  The percentage of DFU and VLU target ulcers achieving complete wound closure. Closure is defined by 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

• Incidence of Adverse events

  1-12 weeks

• Changes to pain associated with the target ulcer

  1-12 weeks

• Determine changes in Quality of Life

  1-12 weeks

Other Outcomes (2)

• Changing in bacterial load

  1-12 weeks

• Changes in ambulation

  1-12 weeks

Study Arms (5)

AIC for DFUs

EXPERIMENTAL

Participants with a diabetic foot ulcer (DFU) will receive treatment with an Amnion-Intermediate-Chorion 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

AIC for VLUs

EXPERIMENTAL

Participants with a venous leg ulcer (VLU) will receive treatment with an Amnion-Intermediate-Chorion sheet, a dehydrated multilayer human placental product 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

ACA for DFUs

EXPERIMENTAL

Participants with a diabetic foot ulcer (DFU) will receive treatment with an Amnion-Chorion-Amnion sheet allograft product, a dehydrated trilayer 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-Chorion-Amnion; Procedure: Standard of Care

ACA for VLUs

EXPERIMENTAL

Participants with a venous leg ulcer (VLU) will receive treatment with an Amnion-Chorion-Amnion allograft sheet, a dehydrated trilayer human placental product 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-Chorion-Amnion; Procedure: Standard of Care

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

Interventions

Amnion-Chorion-Amnion OTHER

Dehydrated human placental trilayer allograft derived from donated human tissue.

Also known as: ACA

ACA for DFUs; ACA for VLUs

Standard of Care 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.

Also known as: SOC

ACA for DFUs; ACA for VLUs; AIC for DFUs; AIC for VLUs; Standard of Care

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.

Also known as: AIC

AIC for DFUs; AIC for VLUs

Eligibility Criteria

• Age: 18 Years - 98 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Potential subjects are required to meet all the following criteria for enrollment into the study and subsequent randomization.
• 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 0.7 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 off-loading 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.
• Potential subjects meeting any of the following criteria will be excluded from enrollment and subsequent randomization.
• 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.
• If there is evidence of osteomyelitis complicating the target ulcer.
• 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.

Sponsors & Collaborators

• Cellution Biologics: lead
• SerenaGroup, Inc.: collaborator
• LifeCell: collaborator

Study Sites (4)

Symphony Research

Jacksonville, Florida, 32257, United States

Location

Sure Step Foot & Ankle

Cincinnati, Ohio, 45249, United States

Location

RGV Wound Care Group

Weslaco, Texas, 78596, United States

Location

Family Foot & Ankle

Kenosha, Wisconsin, 53142, United States

Location

MeSH Terms

Conditions

Diabetic Foot; Varicose Ulcer; Ulcer

Interventions

cancer procoagulant; 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; Varicose Veins; 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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2024
• First Posted: August 20, 2024
• Study Start: October 14, 2024
• Primary Completion: June 11, 2025
• Study Completion: January 16, 2026
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)