RECRUITING

A Study to Evaluate the Efficacy of a Purified Native Type 1 Collagen Extracellular Matrix with Polyhexamethylene Biguanide Antimicrobial (PCMP) and Standard of Care Versus Standard of Care Alone in the Management of Nonhealing Diabetic Foot Ulcers

Conditions

Diabetic Foot Ulcer DFU Chronic Diabetic Foot Ulcer Non-healing DFU

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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

This prospective, multi-center, randomized, controlled modified platform Trial compares Purified Native Type 1 Collagen Extracellular Matrix with Polyhexamethylene Biguanide Antimicrobial (PCMP) and Standard of Care versus Standard of Care Alone in subjects with chronic DFUs.

Official Title

A Multicenter, Prospective, Randomized Controlled Modified Platform Trial Assessing the Efficacy of a Purified Native Type 1 Collagen Extracellular Matrix with Polyhexamethylene Biguanide Antimicrobial (PCMP) and Standard of Care Versus Standard of Care Alone in the Management of Nonhealing Diabetic Foot Ulcers

Quick Facts

Study Start:2024-08-19

Study Completion:2026-11-19

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06618612

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
1. At least 18 years of age or older. 2. Diagnosis of type 1 or 2 Diabetes mellitus. 3. At enrollment, target ulcer with a minimum surface area of 1.0 cm2 4. The target ulcer must have been present for a minimum of 4 weeks 5. The target ulcer must be located on the foot with at least 50% of the ulcer below the malleolus. 6. The target ulcer must be Wagner 1 or 2 grade 7. The affected limb must have adequate perfusion confirmed by vascular assessment. 8. If the potential 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. 9. Target ulcers located on the plantar aspect of the foot must be offloaded for at least 14 days prior to enrollment. 10. The potential subject must consent to using the prescribed offloading method for the duration of the study. 11. The potential subject must agree to attend the weekly study visits required by the protocol. 12. The potential subject must be willing and able to participate in the informed consent process.	1. The potential subject is known to have a life expectancy of \< 6 months. 2. The potential subject's target ulcer is not secondary to diabetes. 3. The target ulcer is infected or there is cellulitis in the surrounding skin. 4. The target ulcer exposes tendon or bone. 5. There is evidence of osteomyelitis 6. There is an infection in the target ulcer or in a remote location that requires systemic antibiotic therapy. 7. The potential subject is receiving immunosuppressants or cytotoxic chemotherapy or is taking medications that the PI believes will interfere with wound healing. 8. The potential subject is taking hydroxyurea. 9. The potential subject has applied topical steroids to the ulcer surface within one month of initial screening. 10. 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. 11. The potential subject has a controlled glycated hemoglobin (HbA1c) within 3 months of the initial screening visit. 12. The potential subject has an acute Charcot foot, or an inactive Charcot foot, which impedes proper offloading of the target ulcer. 13. Women who are pregnant or considering becoming pregnant within the next 6 months. 14. The potential subject has end stage renal disease requiring dialysis. 15. Participation in a clinical trial involving treatment with an investigational product within the previous 30 days. 16. A potential subject who, in the opinion of the investigator, has a medical or psychological condition that may interfere with study assessments. 17. The potential subject was treated with hyperbaric oxygen therapy (HBOT) or a Cellular, Acellular, Matrix-like Product (CAMP) in the 30 days prior to the initial screening visit. 18. The potential subject has a malnutrition indicator score \<17 as measured on the Mini Nutritional Assessment.

Inclusion Criteria

Exclusion Criteria

1. At least 18 years of age or older.
2. Diagnosis of type 1 or 2 Diabetes mellitus.
3. At enrollment, target ulcer with a minimum surface area of 1.0 cm2
4. The target ulcer must have been present for a minimum of 4 weeks
5. The target ulcer must be located on the foot with at least 50% of the ulcer below the malleolus.
6. The target ulcer must be Wagner 1 or 2 grade
7. The affected limb must have adequate perfusion confirmed by vascular assessment.
8. If the potential 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.
9. Target ulcers located on the plantar aspect of the foot must be offloaded for at least 14 days prior to enrollment.
10. The potential subject must consent to using the prescribed offloading method for the duration of the study.
11. The potential subject must agree to attend the weekly study visits required by the protocol.
12. The potential subject must be willing and able to participate in the informed consent process.

1. The potential subject is known to have a life expectancy of \< 6 months.
2. The potential subject's target ulcer is not secondary to diabetes.
3. The target ulcer is infected or there is cellulitis in the surrounding skin.
4. The target ulcer exposes tendon or bone.
5. There is evidence of osteomyelitis
6. There is an infection in the target ulcer or in a remote location that requires systemic antibiotic therapy.
7. The potential subject is receiving immunosuppressants or cytotoxic chemotherapy or is taking medications that the PI believes will interfere with wound healing.
8. The potential subject is taking hydroxyurea.
9. The potential subject has applied topical steroids to the ulcer surface within one month of initial screening.
10. 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.
11. The potential subject has a controlled glycated hemoglobin (HbA1c) within 3 months of the initial screening visit.
12. The potential subject has an acute Charcot foot, or an inactive Charcot foot, which impedes proper offloading of the target ulcer.
13. Women who are pregnant or considering becoming pregnant within the next 6 months.
14. The potential subject has end stage renal disease requiring dialysis.
15. Participation in a clinical trial involving treatment with an investigational product within the previous 30 days.
16. A potential subject who, in the opinion of the investigator, has a medical or psychological condition that may interfere with study assessments.
17. The potential subject was treated with hyperbaric oxygen therapy (HBOT) or a Cellular, Acellular, Matrix-like Product (CAMP) in the 30 days prior to the initial screening visit.
18. The potential subject has a malnutrition indicator score \<17 as measured on the Mini Nutritional Assessment.

Contacts and Locations

Study Contact

Brett Madden

CONTACT

(781) 575-0775

bmadden@organo.com

Meghan Byrd

CONTACT

(781) 575-0775

mbyrd@organo.com

Principal Investigator

Maribel Henao

STUDY_DIRECTOR

Organogenesis

Study Locations (Sites)

Kent State University, College of Podiatric Medicine

Clevland, Ohio, 44103

United States

Collaborators and Investigators

Sponsor: Organogenesis

Maribel Henao, STUDY_DIRECTOR, Organogenesis

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 Date2024-08-19

Study Completion Date2026-11-19

Study Record Updates

Study Start Date2024-08-19

Study Completion Date2026-11-19

Terms related to this study

Keywords Provided by Researchers

DFU
Chronic Diabetic Foot Ulcer
Non-healing DFU

Additional Relevant MeSH Terms

Diabetic Foot Ulcer