Mirragen Diabetic Foot Ulcer Study

NCT06598241 | Recruiting

• 1 other identifier: STUDY00000049
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Diabetic Foot Ulcer; Osteomyelitis Chronic

Keywords

Glass fiber matrix

Outcome Measures

Primary Outcomes (1)

• Complete Wound Closure

  Number of patients to achieve complete wound closure. Complete wound closure is defined as skin re-epithelialization without drainage or dressing requirements confirmed at 2 consecutive study visits 2 weeks apart.

  Week 12

Secondary Outcomes (9)

• 60% Reduction in wound size

  Baseline to 12 weeks

• Pain level using Visual Analog Scale

  Baseline to 12 weeks

• Change in Lower Extremity Function Scale (LEFS )

  Baseline to 12 weeks

• Number of Adverse Events related to BBGFM

  Baseline to 12 weeks

• Number of subjects with either cellulitis, infection and/or osteomyelitis

  Baseline to 12 weeks

Study Arms (1)

Diabetic Foot Ulcer Treatment Group

Male or female between ≥ 18 years and ≤ 80 years of age that are scheduled to receive treatment of the commercially available borate-based bioactive glass fiber matrix will be enrolled in the study

Device: Borate-base Bioactive Glass Fiber Matrix (BBGFM)

Interventions

Borate-base Bioactive Glass Fiber Matrix (BBGFM) DEVICE

Bioactive glass materials are biocompatible water-soluble inorganic ceramic materials that release their constituent ions when immersed in body fluids.

Diabetic Foot Ulcer Treatment Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who are scheduled to receive treatment of commercially available borate-based bioactive glass fiber matrix (BBGFM) at the Medical Arts and Research Center (MARC) and Texas Diabetes Institute (TDI) will be considered potential subjects and will be pre-screened.

You may qualify if:

• The subject has signed the informed consent form
• Subject is male or female aged between ≥ 18 or ≤ 80
• Subject scheduled to receive borate-based bioactive glass fiber matrix in treatment of index diabetic foot ulcer
• Index ulcer has not received an application of BBFGM previously
• Subjects with insurance coverage for BBGFM
• Subject has documented Type 1 or Type 2 diabetes with an HbA1c less than or equal to 12.0% within 90 days of enrollment.
• The subject is under the care of Physician for the management of Diabetes Mellitus
• Subject must have a wound present anatomically on the foot as defined by beginning below the malleoli of the ankle, dorsal surface, plantar surface, inter digital, heel, lateral or medial surface of the foot
• Subject index ulcers must be ≥ 0.5 cm2 and ≤ 8.0 cm2
• Index ulcer has been present for greater than 4 weeks prior to enrollment and less than 2-years, as of the date the subject receives the BBGFM
• The BBGFM will be applied in an outpatient setting
• Subject has an ulcer with a Wagner Grade 2 or 3 classification Wagner Grade 2: Deep ulcer extended to ligament, tendon, joint capsule, bone, or deep fascia without abscess or osteomyelitis Wagner Grade 3: Ulcers extend to the deep tissue and have either associated soft tissue abscess or osteomyelitis If Wagner Grade 3 Ulcer with chronic osteomyelitis, that can be debrided in an outpatient setting, in the opinion of the investigator
• Exposed or palpable bone in the reference ulcer, that can be surgically excised in an outpatient clinic setting, using local anesthetic, at the screening or randomization visit
• Less than a 1cm margin of peri-ulcer tissue of the reference ulcer, requiring surgical debridement, at the screening and randomization visit
• Wagner Grade 3 subjects must have osteomyelitis diagnosed by:

You may not qualify if:

• Subject is unwilling to sign informed consent
• Subjects who cannot obtain insurance coverage for BBFGM
• The BBFGM cannot be applied in an outpatient setting
• Index ulcer has previously received an application of BBFGM
• Subject has a major contralateral amputation of lower extremity, specifically transmetatarsal amputation or more proximal amputation
• Subject index ulcer has a known history of borate-base bioactive glass fiber matrix application
• Subject is pregnant or breast-feeding.
• Subject index ulcer associated with carcinoma.
• Subject has active Charcot Neuroarthropathy
• Subject requires extensive soft tissue and bone debridement in the operating room
• Subject has a life expectancy of less than six months as assessed by the investigator.
• Subject not in reasonable metabolic control in the judgment of the investigator
• Subject with a known history of poor compliance with medical treatments
• Subject currently undergoing cancer treatment
• Subject has been on oral steroid use of \<7.5 mg daily for greater than seven consecutive days in 30 days before screening

Sponsors & Collaborators

• The University of Texas Health Science Center at San Antonio: lead

Study Sites (1)

UT Health Medical Arts and Research Center

San Antonio, Texas, 78229, United States

RECRUITING

MeSH Terms

Conditions

Diabetic Foot

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

Study Officials

• Cyaandi R Dove, DPM

  The University of Texas Health Science Center at San Antonio

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cyaandi R Dove, DPM

CONTACT

210-567-5135; dovec@uthscsa.edu

Henrik Claeson

CONTACT

210-567-8279; claeson@uthscsa.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2024
• First Posted: September 19, 2024
• Study Start: September 20, 2024
• Primary Completion: May 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: May 22, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: At the time of publication in a peer-review journal

Locations

US (1)