RECRUITING

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

Conditions

Diabetic Foot Ulcer DFU Diabetic Ulcer Foot Wound Placenta

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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

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.

Official Title

A Multicenter, Randomized Trial Evaluating Dehydrated Human Placenta Tissue (dHPT) and Standard of Care Versus Standard of Care Alone in Nonhealing Diabetic Foot Ulcers

Quick Facts

Study Start:2025-06-22

Study Completion:2026-10-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT07014176

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
Age 18 years or older Willing and able to provide informed consent Able to understand and follow study procedures Stable medical condition	1. Known life expectancy of \< 6 months. 2. Target ulcer is not secondary to diabetes. 3. Target ulcer is infected or there is cellulitis in the surrounding skin. 4. Evidence of osteomyelitis complicating the target ulcer. 5. Infection in the target ulcer or a location that requires systemic antibiotic therapy. 6. Receiving immunosuppressants (including systemic corticosteroids at doses greater than 10 mg of Prednisone per day or equivalent) or cytotoxic chemotherapy is excluded. 7. Topical application of steroids to the ulcer surface within one month of screening. 8. Previous partial amputation on the affected foot if the resulting deformity impedes proper offloading of the target ulcer. 9. 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). 10. Mini Nutritional Assessment (MNA) score of less than 17. 11. Acute Charcot foot or an inactive Charcot foot that impedes proper offloading of the target ulcer. 12. Women of childbearing potential (WOCBP) who are pregnant, considering becoming pregnant within the next 4 months, or are unwilling to use an appropriate form of contraception. 13. Currently require dialysis or planning to start dialysis. 14. Medical or psychological condition that, in the opinion of the investigator, may interfere with study assessments. 15. Treated with hyperbaric oxygen therapy or a dehydrated human placental tissue (dHTP) in the 30 days prior to screening visit. 16. Known sensitivity to ofloxacin, vancomycin, or amphotericin antibiotics. 17. Participation in a clinical trial involving treatment with an investigational product within the previous 30 days.

Inclusion Criteria

Exclusion Criteria

Age 18 years or older
Willing and able to provide informed consent
Able to understand and follow study procedures
Stable medical condition

1. Known life expectancy of \< 6 months.
2. Target ulcer is not secondary to diabetes.
3. Target ulcer is infected or there is cellulitis in the surrounding skin.
4. Evidence of osteomyelitis complicating the target ulcer.
5. Infection in the target ulcer or a location that requires systemic antibiotic therapy.
6. Receiving immunosuppressants (including systemic corticosteroids at doses greater than 10 mg of Prednisone per day or equivalent) or cytotoxic chemotherapy is excluded.
7. Topical application of steroids to the ulcer surface within one month of screening.
8. Previous partial amputation on the affected foot if the resulting deformity impedes proper offloading of the target ulcer.
9. 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).
10. Mini Nutritional Assessment (MNA) score of less than 17.
11. Acute Charcot foot or an inactive Charcot foot that impedes proper offloading of the target ulcer.
12. Women of childbearing potential (WOCBP) who are pregnant, considering becoming pregnant within the next 4 months, or are unwilling to use an appropriate form of contraception.
13. Currently require dialysis or planning to start dialysis.
14. Medical or psychological condition that, in the opinion of the investigator, may interfere with study assessments.
15. Treated with hyperbaric oxygen therapy or a dehydrated human placental tissue (dHTP) in the 30 days prior to screening visit.
16. Known sensitivity to ofloxacin, vancomycin, or amphotericin antibiotics.
17. Participation in a clinical trial involving treatment with an investigational product within the previous 30 days.

Contacts and Locations

Study Contact

Bryanna Finstein, BS

CONTACT

6035574660

bryanna.f@cellutionbiologics.com

Cellution Research

CONTACT

6035574660

clinical@cellutionbiologics.com

Principal Investigator

Research Director

STUDY_DIRECTOR

Cellution Biologics

Study Locations (Sites)

004

Mission Viejo, California, 92691

United States

001

Jacksonville, Florida, 32216

United States

003

Chicago, Illinois, 60611

United States

002

Rocky Mount, North Carolina, 27804

United States

Collaborators and Investigators

Sponsor: Cellution Biologics

Research Director, STUDY_DIRECTOR, Cellution Biologics

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 Date2025-06-22

Study Completion Date2026-10-31

Study Record Updates

Study Start Date2025-06-22

Study Completion Date2026-10-31

Terms related to this study

Keywords Provided by Researchers

DFU
Diabetic Ulcer
Foot Wound
Diabetic Foot Ulcer
Placenta

Additional Relevant MeSH Terms

Diabetic Foot Ulcer