Actively Recruiting
Mirragen Diabetic Foot Ulcer Study
Led by The University of Texas Health Science Center at San Antonio · Updated on 2025-05-22
20
Participants Needed
1
Research Sites
110 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is being done to collect data from treatment of patients who have diabetes with non-healing foot wounds and are being treated with a resorbable and biocompatible borate-based bioactive glass fiber matrix. A borate-based bioactive glass fiber matrix is used to cover the ulcer for wound management. The primary objective of this study is to evaluate the safety and efficacy of the borate-based bioactive glass fiber matrix in the treatment of diabetic foot ulcers in a real-world setting. The secondary objective is to evaluate the clinical and financial benefits in terms of quality of healing, pain, and treatment cost.
CONDITIONS
Official Title
Mirragen Diabetic Foot Ulcer Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent form
- Male or female aged between 18 and 80 years
- Scheduled to receive borate-based bioactive glass fiber matrix for treatment of diabetic foot ulcer
- Index ulcer has not previously received this bioactive glass fiber matrix
- Has insurance coverage for the treatment
- Documented type 1 or type 2 diabetes with HbA1c ≤ 12.0% within 90 days before enrollment
- Under physician care for diabetes management
- Wound located on the foot below the ankle malleoli
- Ulcer size between 0.5 cm2 and 8.0 cm2
- Ulcer present for more than 4 weeks and less than 2 years before treatment
- Treatment applied in an outpatient setting
- Ulcer classified as Wagner Grade 2 or 3; Grade 3 ulcers with chronic osteomyelitis eligible if debridement can be done outpatient
- No need for surgical debridement in operating room
- No active cellulitis at the ulcer site
- Willingness to comply with dressing treatment and study visits
- Willingness to use offloading device
- If female, practicing adequate contraception and willing to use birth control during study
- Adequate circulation to affected foot confirmed by specified vascular tests within 60 days
You will not qualify if you...
- Unwilling to sign informed consent
- No insurance coverage for treatment
- Treatment cannot be applied outpatient
- Ulcer has previously received the bioactive glass fiber matrix
- Major amputation on opposite leg
- Known history of prior use of the bioactive glass fiber matrix on the ulcer
- Pregnant or breastfeeding
- Ulcer associated with cancer
- Active Charcot Neuroarthropathy
- Requires extensive surgical debridement in operating room
- Life expectancy less than six months
- Poor metabolic control as judged by investigator
- History of poor compliance with medical treatments
- Undergoing cancer treatment
- Recent oral steroid or cytotoxic agent use as specified
- History of cancer (except non-melanoma skin) within five years
- Diagnosed with certain serious diseases including lupus, AIDS, HIV, or uncontrolled rheumatoid arthritis
- Receiving radiation or chemotherapy
- On or planning dialysis
- Conditions impairing study compliance or understanding
- Unable to sustain or use offloading device
- Ulcer with acute osteomyelitis or active cellulitis
- Expected use of Negative Pressure Wound Therapy on ulcer
- Permanently non-ambulatory
- Women unwilling to avoid pregnancy or use proper birth control
- Allergic to dressing materials used
- Investigator deems subject unsuitable due to sepsis or other factors
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
UT Health Medical Arts and Research Center
San Antonio, Texas, United States, 78229
Actively Recruiting
Research Team
C
Cyaandi R Dove, DPM
CONTACT
H
Henrik Claeson
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here