RECRUITING

Mirragen Diabetic Foot Ulcer Study

Conditions

Diabetic Foot Ulcer Osteomyelitis Chronic Glass fiber matrix

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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 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.

Official Title

A Pilot, Post-market, Non-interventional, Prospective, Observational Study of Standard of Care of the Commercially Available Borate-base Bioactive Glass Fiber Matrix (BBGFM) in Treatment of Outpatient Diabetic Foot Ulcer With Chronic Osteomyelitis.

Quick Facts

Study Start:2024-09-20

Study Completion:2025-10

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06598241

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 to 80 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. The subject has signed the informed consent form 2. Subject is male or female aged between ≥ 18 or ≤ 80 3. Subject scheduled to receive borate-based bioactive glass fiber matrix in treatment of index diabetic foot ulcer 4. Index ulcer has not received an application of BBFGM previously 5. Subjects with insurance coverage for BBGFM 6. Subject has documented Type 1 or Type 2 diabetes with an HbA1c less than or equal to 12.0% within 90 days of enrollment. 7. The subject is under the care of Physician for the management of Diabetes Mellitus 8. 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 9. Subject index ulcers must be ≥ 0.5 cm2 and ≤ 8.0 cm2 10. 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 11. The BBGFM will be applied in an outpatient setting 12. 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 1. 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 2. Less than a 1cm margin of peri-ulcer tissue of the reference ulcer, requiring surgical debridement, at the screening and randomization visit 13. Subject does not require a surgical debridement in the operating room 14. Subjects without active cellulitis at the index ulcer 15. Subject or responsible caregiver is willing to comply with the dressing treatment and study visits 16. Subject is willing to utilize the offloading device to offload wound 17. If female, subjects must have been practicing adequate contraception (abstinence, barrier method, hormonal, or IUD). Must agree to using an accepted and effective form of birth control during the study. 18. Subject has adequate circulation to the affected extremity, as demonstrated by at least ONE of the following tests within 60 days (about 2 months) prior to enrollment:	1. Subject is unwilling to sign informed consent 2. Subjects who cannot obtain insurance coverage for BBFGM 3. The BBFGM cannot be applied in an outpatient setting 4. Index ulcer has previously received an application of BBFGM 5. Subject has a major contralateral amputation of lower extremity, specifically transmetatarsal amputation or more proximal amputation 6. Subject index ulcer has a known history of borate-base bioactive glass fiber matrix application 7. Subject is pregnant or breast-feeding. 8. Subject index ulcer associated with carcinoma. 9. Subject has active Charcot Neuroarthropathy 10. Subject requires extensive soft tissue and bone debridement in the operating room 11. Subject has a life expectancy of less than six months as assessed by the investigator. 12. Subject not in reasonable metabolic control in the judgment of the investigator 13. Subject with a known history of poor compliance with medical treatments 14. Subject currently undergoing cancer treatment 15. Subject has been on oral steroid use of \<7.5 mg daily for greater than seven consecutive days in 30 days before screening 16. Subject is taking parenteral corticosteroids or any cytotoxic agents for seven consecutive days in the period of 30 days before screening 17. The subject has malignancy or a history of cancer, other than non-melanoma skin cancer, in five years before screening 18. Subject has been diagnosed or had medical history with at least one of the following diseases: cancer, lupus, vasculitis, sickle cell, fibromyalgia, acquired immunodeficiency syndrome (AIDS) or HIV, uncontrolled rheumatoid arthritis, stage renal disease. 19. Subject currently receiving radiation therapy or chemotherapy. 20. Patient currently on dialysis or planning to start dialysis. 21. Presence of any condition that is likely to impair understanding of or compliance with the study protocol in the judgment of the Investigator 22. Subject is unable to sustain off-loading as defined by the protocol 23. Subject index ulcer that cannot be offload by an offloading device 24. Subject index ulcer with acute osteomyelitis, as per no bony changes on x-ray and/or presence of acute cellulitis at the index ulcer 25. Subject is anticipated to use Negative Pressure Wound Therapy (NPWT) on the index ulcer during the study 26. Subjects who are permanently non-ambulatory (i.e. wheelchair bound) 27. The subject is a woman of child-bearing potential who is unwilling to avoid pregnancy or use an appropriate form of birth control (adequate birth control methods are defined as: topical, oral, implantable, or injectable contraceptives; spermicide in conjunction with a barrier such as a condom or diaphragm; IUD; or surgical sterilization of partner) 28. Subject has an allergy to primary or secondary dressing materials used in this trial 29. In the opinion of the Investigator the subject is not appropriate for inclusion in the trial, e.g., undergoing surgical treatments listed in the protocol or subject currently has sepsis, i.e., life threatening organ dysfunction caused by a dysregulated host response to infection

Inclusion Criteria

Exclusion Criteria

1. The subject has signed the informed consent form
2. Subject is male or female aged between ≥ 18 or ≤ 80
3. Subject scheduled to receive borate-based bioactive glass fiber matrix in treatment of index diabetic foot ulcer
4. Index ulcer has not received an application of BBFGM previously
5. Subjects with insurance coverage for BBGFM
6. Subject has documented Type 1 or Type 2 diabetes with an HbA1c less than or equal to 12.0% within 90 days of enrollment.
7. The subject is under the care of Physician for the management of Diabetes Mellitus
8. 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
9. Subject index ulcers must be ≥ 0.5 cm2 and ≤ 8.0 cm2
10. 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
11. The BBGFM will be applied in an outpatient setting
12. 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
1. 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
2. Less than a 1cm margin of peri-ulcer tissue of the reference ulcer, requiring surgical debridement, at the screening and randomization visit
13. Subject does not require a surgical debridement in the operating room
14. Subjects without active cellulitis at the index ulcer
15. Subject or responsible caregiver is willing to comply with the dressing treatment and study visits
16. Subject is willing to utilize the offloading device to offload wound
17. If female, subjects must have been practicing adequate contraception (abstinence, barrier method, hormonal, or IUD). Must agree to using an accepted and effective form of birth control during the study.
18. Subject has adequate circulation to the affected extremity, as demonstrated by at least ONE of the following tests within 60 days (about 2 months) prior to enrollment:

1. Subject is unwilling to sign informed consent
2. Subjects who cannot obtain insurance coverage for BBFGM
3. The BBFGM cannot be applied in an outpatient setting
4. Index ulcer has previously received an application of BBFGM
5. Subject has a major contralateral amputation of lower extremity, specifically transmetatarsal amputation or more proximal amputation
6. Subject index ulcer has a known history of borate-base bioactive glass fiber matrix application
7. Subject is pregnant or breast-feeding.
8. Subject index ulcer associated with carcinoma.
9. Subject has active Charcot Neuroarthropathy
10. Subject requires extensive soft tissue and bone debridement in the operating room
11. Subject has a life expectancy of less than six months as assessed by the investigator.
12. Subject not in reasonable metabolic control in the judgment of the investigator
13. Subject with a known history of poor compliance with medical treatments
14. Subject currently undergoing cancer treatment
15. Subject has been on oral steroid use of \<7.5 mg daily for greater than seven consecutive days in 30 days before screening
16. Subject is taking parenteral corticosteroids or any cytotoxic agents for seven consecutive days in the period of 30 days before screening
17. The subject has malignancy or a history of cancer, other than non-melanoma skin cancer, in five years before screening
18. Subject has been diagnosed or had medical history with at least one of the following diseases: cancer, lupus, vasculitis, sickle cell, fibromyalgia, acquired immunodeficiency syndrome (AIDS) or HIV, uncontrolled rheumatoid arthritis, stage renal disease.
19. Subject currently receiving radiation therapy or chemotherapy.
20. Patient currently on dialysis or planning to start dialysis.
21. Presence of any condition that is likely to impair understanding of or compliance with the study protocol in the judgment of the Investigator
22. Subject is unable to sustain off-loading as defined by the protocol
23. Subject index ulcer that cannot be offload by an offloading device
24. Subject index ulcer with acute osteomyelitis, as per no bony changes on x-ray and/or presence of acute cellulitis at the index ulcer
25. Subject is anticipated to use Negative Pressure Wound Therapy (NPWT) on the index ulcer during the study
26. Subjects who are permanently non-ambulatory (i.e. wheelchair bound)
27. The subject is a woman of child-bearing potential who is unwilling to avoid pregnancy or use an appropriate form of birth control (adequate birth control methods are defined as: topical, oral, implantable, or injectable contraceptives; spermicide in conjunction with a barrier such as a condom or diaphragm; IUD; or surgical sterilization of partner)
28. Subject has an allergy to primary or secondary dressing materials used in this trial
29. In the opinion of the Investigator the subject is not appropriate for inclusion in the trial, e.g., undergoing surgical treatments listed in the protocol or subject currently has sepsis, i.e., life threatening organ dysfunction caused by a dysregulated host response to infection

Contacts and Locations

Study Contact

Cyaandi R Dove, DPM

CONTACT

210-567-5135

dovec@uthscsa.edu

Henrik Claeson

CONTACT

210-567-8279

claeson@uthscsa.edu

Principal Investigator

Cyaandi R Dove, DPM

PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center at San Antonio

Study Locations (Sites)

UT Health Medical Arts and Research Center

San Antonio, Texas, 78229

United States

Collaborators and Investigators

Sponsor: The University of Texas Health Science Center at San Antonio

Cyaandi R Dove, DPM, PRINCIPAL_INVESTIGATOR, The University of Texas Health Science Center at San Antonio

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 Date2024-09-20

Study Completion Date2025-10

Study Record Updates

Study Start Date2024-09-20

Study Completion Date2025-10

Terms related to this study

Keywords Provided by Researchers

Glass fiber matrix

Additional Relevant MeSH Terms

Diabetic Foot Ulcer
Osteomyelitis Chronic