Efficacy of ProgenaMatrix™ in the Management of DFUs

NCT06292026 | Active Not Recruiting DMC FDA Device

• 1 other identifier: DFU/1
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This multicenter study will collect data to determine closure time for diabetic ulcers when following protocol parameters and treatment with ProgenaMatrix™.

Conditions

Diabetic Foot Ulcer

Outcome Measures

Primary Outcomes (1)

• time to wound closure

  The endpoint of this data collection process is to study the timepoint for total wound closure following the protocol procedures in the use of ProgenaMatrix™.

  12 weeks of treatment

Study Arms (1)

Treatment with ProgenaMatrix

EXPERIMENTAL

application of ProgenaMatrix daily for 12 weeks

Device: ProgenaMatrix Keratin graft; Other: standard of care

Interventions

ProgenaMatrix Keratin graft DEVICE

place ProgenaMatrix graft on the wound

Treatment with ProgenaMatrix

standard of care OTHER

apply non adherent dressing

Also known as: adaptic

Treatment with ProgenaMatrix

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Understands and agrees that the standard treatment protocol will include the application of ProgenaMatrix™ as the standard of care for this project.
• Have participated in the informed consent process and signed a data collection and treatment specific informed consent.
• Be able and willing to comply with the data collection procedures, data collection visits, dressings, and off-loading.
• Have type I or type II diabetes mellitus with an Investigator-confirmed glycosylated hemoglobin (HBA1c) of less than or equal to 11.5% within 3 months prior treatment.
• Have at least one DFU Ulcer that has been in existence for a minimum of 4 weeks but no more than 12 months and meets all the following criteria:
• Ulcer is partial or full thickness without capsule/tendon/bone exposure.
• Ulcer is on the foot or ankle.
• Ulcer area is greater than 1 sq. cm. but less than 18 sq. cm. post debridement. (Ulcers larger than 18 sq. cm. can be included with the approval of the Medical Monitor.)
• If the subject has more than one ulcer the data collection ulcer will be at the discretion of the Investigator.
• There is minimum of 1 cm between the ulcer treated and any other ulcer on the same foot.
• Have adequate vascular perfusion of the affected limb as defined by one of the following in order of preference.
• Ankle-Brachial index of greater than .65 and less the 1.3
• Toe Pressure of greater than 40 mmHg
• TcPO2 of greater than 40 mmHg

You may not qualify if:

• The study ulcer has unexplored tunneling, undermining, or sinus tracts.
• The patient is unable to safely ambulate with appropriate off-loading device.
• The patient has a known sensitivity to the suggested dressings.
• The patient has or is suspected of having gangrene, wound infection, necrosis, redness, pain, purulent drainage or is being treated by antibiotic for the treatment of the above.
• The patient has confirmed osteomyelitis of the foot with the ulcer.
• The patient is on steroid therapy, immunosuppressive or autoimmune therapy, radiation therapy of the foot, thrombosis.
• History of bone of metastatic disease of the affected limb, radiation therapy or chemotherapy within 12 months prior to treatment.
• Pregnancy
• The patient is affected by any disease other than diabetes that can impair wound healing in the opinion of the Investigator.
• The patient has unstable Charcot with bony prominence that will inhibit wound healing.
• Excessive lymphedema that will inhibit off-loading.
• Is unwilling to allow the use ProgenaMatrix™ as the standard of care for this data collection project.

Sponsors & Collaborators

• ProgenaCare Global, LLC: lead

Study Sites (1)

United Wound Healing

Puyallup, Washington, 98371, United States

Location

MeSH Terms

Conditions

Diabetic Foot

Interventions

Standard of Care; Bisphenol A-Glycidyl Methacrylate

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

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Methacrylates; Acrylates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Bisphenol A Compounds; Bisphenols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Composite Resins; Resins, Synthetic; Plastics; Polymers; Macromolecular Substances; Dental Materials; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The objective of this data collection is to look at outcomes and time points for ProgenaMatrix™ in the treatment of diabetic foot ulcers. Additionally, use the collected data to develop predictive wound closure models. There is a 1-week lead in period after initial debridement. If the wound is rapidly moving to closure after initial debridement and standard moist dressings, the withdrawal of these patients will prevent corruption of the true closure rate of ProgenaMatrix™. The objective of the treatment with ProgenaMatrix™ is to evaluate the closure rate in patients not responding to traditional moist therapy.

Study Record Dates

• First Submitted: February 22, 2024
• First Posted: March 4, 2024
• Study Start: March 14, 2022
• Primary Completion: March 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: March 4, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)