RECRUITING

A Multicenter, Prospective, Controlled Clinical Trial Evaluating the Efficacy of a Single Layer Placental-based Allograft and Standard of Care in the Management of Nonhealing Diabetic Foot Ulcers

Conditions

Diabetic Foot Foot Ulcer Ulcer Foot DFU Foot Ulcer Due to Type 2 Diabetes Mellitus Foot Ulcer Due to Type 1 Diabetes Mellitus Diabetic Foot Ulcer

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

A multicenter, prospective, controlled clinical trial evaluating the efficacy of a single layer placental-based allograft and standard of care in the management of nonhealing diabetic foot ulcers.

Official Title

A Multicenter, Prospective, Controlled Clinical Trial Evaluating the Efficacy of a Single Layer Placental-based Allograft and Standard of Care in the Management of Nonhealing Diabetic Foot Ulcers

Quick Facts

Study Start:2025-08-26

Study Completion:2027-08

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT07159282

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* The potential subject must be at least 18 years of age or older. * The potential subject must have a diagnosis of type 1 or 2 Diabetes mellitus. * If the potential subject has two or more ulcers, the target ulcer must be the same ulcer treated in the CAMPX study. * The potential subject must consent to using the prescribed offloading method for the duration of the study. * The potential subject must agree to attend the weekly study visits required by the protocol. * The potential subject must be willing and able to participate in the informed consent process. * The potential subject must have participated in the CAMPX trial in the SOC only arm and NOT achieved complete closure by the 12-week endpoint.	* The potential subject is known to have a life expectancy of \< 6 months. * The potential subject's target ulcer is not secondary to diabetes. * The target ulcer is infected or there is cellulitis in the surrounding skin. * The target ulcer exposes tendon or bone. * There is evidence of osteomyelitis complicating the target ulcer. * There is an infection in the target ulcer or in a remote location that requires systemic antibiotic therapy. * The potential subject is receiving immunosuppressants (including systemic corticosteroids at doses greater than 10 mg of prednisone per day or equivalent) or cytotoxic chemotherapy or is taking medications that the PI believes will interfere with wound healing (e.g., biologics). * The potential subject has applied topical steroids to the ulcer surface within one month of initial screening. * The potential subject with a previous partial amputation on the affected foot that results in a deformity that impedes proper offloading of the target ulcer. * The potential subject has glycated hemoglobin (HbA1c) greater than or equal to 12% within 3 months of the initial screening visit. * The potential subject has an acute Charcot foot, or an inactive Charcot foot, which impedes proper offloading of the target ulcer. * The potential subject is a woman who is pregnant or considering becoming pregnant within the next 6 months. * The potential subject has end stage renal disease requiring dialysis. * The potential subject, in the opinion of the investigator, has a medical or psychological condition that may interfere with study assessments. * The potential subject has a malnutrition indicator score \<17 as measured on the Mini Nutritional Assessment. * The potential subject did not participate in the CAMPX trial. * The potential subject participated in the CAMPX trial and was not randomized to the SOC only arm. * The potential subject participated in the CAMPX trial and achieved complete closure.

Inclusion Criteria

Exclusion Criteria

* The potential subject must be at least 18 years of age or older.
* The potential subject must have a diagnosis of type 1 or 2 Diabetes mellitus.
* If the potential subject has two or more ulcers, the target ulcer must be the same ulcer treated in the CAMPX study.
* The potential subject must consent to using the prescribed offloading method for the duration of the study.
* The potential subject must agree to attend the weekly study visits required by the protocol.
* The potential subject must be willing and able to participate in the informed consent process.
* The potential subject must have participated in the CAMPX trial in the SOC only arm and NOT achieved complete closure by the 12-week endpoint.

* The potential subject is known to have a life expectancy of \< 6 months.
* The potential subject's target ulcer is not secondary to diabetes.
* The target ulcer is infected or there is cellulitis in the surrounding skin.
* The target ulcer exposes tendon or bone.
* There is evidence of osteomyelitis complicating the target ulcer.
* There is an infection in the target ulcer or in a remote location that requires systemic antibiotic therapy.
* The potential subject is receiving immunosuppressants (including systemic corticosteroids at doses greater than 10 mg of prednisone per day or equivalent) or cytotoxic chemotherapy or is taking medications that the PI believes will interfere with wound healing (e.g., biologics).
* The potential subject has applied topical steroids to the ulcer surface within one month of initial screening.
* The potential subject with a previous partial amputation on the affected foot that results in a deformity that impedes proper offloading of the target ulcer.
* The potential subject has glycated hemoglobin (HbA1c) greater than or equal to 12% within 3 months of the initial screening visit.
* The potential subject has an acute Charcot foot, or an inactive Charcot foot, which impedes proper offloading of the target ulcer.
* The potential subject is a woman who is pregnant or considering becoming pregnant within the next 6 months.
* The potential subject has end stage renal disease requiring dialysis.
* The potential subject, in the opinion of the investigator, has a medical or psychological condition that may interfere with study assessments.
* The potential subject has a malnutrition indicator score \<17 as measured on the Mini Nutritional Assessment.
* The potential subject did not participate in the CAMPX trial.
* The potential subject participated in the CAMPX trial and was not randomized to the SOC only arm.
* The potential subject participated in the CAMPX trial and achieved complete closure.

Contacts and Locations

Study Contact

Bennett Sarver

CONTACT

888-960-1343

bsarver@serenagroups.com

Thomas Serena, MD

CONTACT

814-688-4000

tserena@serenagroups.com

Study Locations (Sites)

Royal Research

Hollywood, Florida, 33024

United States

Collaborators and Investigators

Sponsor: Applied Biologics, LLC

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-08-26

Study Completion Date2027-08

Study Record Updates

Study Start Date2025-08-26

Study Completion Date2027-08

Terms related to this study

Additional Relevant MeSH Terms

Diabetic Foot
Foot Ulcer
Ulcer Foot
DFU
Foot Ulcer Due to Type 2 Diabetes Mellitus
Foot Ulcer Due to Type 1 Diabetes Mellitus
Diabetic Foot Ulcer