Bioresorbable Glass Fiber Matrix in the Treatment of Diabetic Foot Ulcers

Diabetic Foot Ulcer Clinical Trial

— BGWM  

Official title:

A Randomized Controlled Clinical Trial Evaluating The Efficacy Of A Borate-Based Bioactive Glass Advanced Wound Matrix And Standard Of Care Versus Standard Of Care Alone

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06403605
• Other study ID #: ETS-MG-DFU-02
• Status: Recruiting
• Phase: N/A
• Start date: August 29, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: May 2023
• Source: ETS Wound Care, LLC
• Contact: Donald W Buck II, MD
• Phone: 510-490-5998
• Email: dbuck[@]etswoundcare.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is a prospective, multi-center, randomized controlled trial designed to collect patient outcome data on 2 commercially available SOC treatments for Diabetic Foot Wounds.

Description:

This study is a prospective, multi-center, RCT designed to collect patient outcome data on two commercially available SOC treatments for DFUs. The trial will be single blinded in regard to wound healing assessment (another clinician, other than the investigator at each site will assess wound healing) and confirmation of wound healing will be overseen by an independent adjudication committee made up of wound care experts. The study will last twelve weeks, with a two week screening period prior to enrollment.

There are two standard of care arms in the study:

Arm 1: The SOC therapy in this study is offloading of the DFU (CAM boots or total contact casting [TCC] if the subject's foot is too large for a CAM), appropriate sharp or surgical debridement, infection management (systemic antibiotics only in conjunction with debridement) and wound care covering with bioactive resorbable glass fiber, MIRRAGEN™ Advanced Wound Matrix, followed by a padded 3-layer dressing comprised of 4x4 gauze pads, soft roll and compressive wrap (DynaflexTM or equivalent).

ARM 2: The SOC therapy in the study is offloading of the DFU (CAM boots or total contact casting [TCC] if the subject's foot is too large for a CAM), appropriate sharp or surgical debridement, infection management (systemic antibiotics only in conjunction with debridement) and wound care covering with calcium alginate Fibracol dressing follwed by a padded 3-layer dressing comprised of 4x4 gauze pads, soft roll and compressive wrap (DynaflexTM or equivalent).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Subjects must be at least 18 years of age or older.

2. Subjects must have a diagnosis of type 1 or 2 Diabetes mellitus.

3. At randomization subjects must have a target diabetic foot ulcer with a minimum surface area of 1.0 cm2 and a maximum surface area of 20.0 cm2 measured post debridement with a photographic planimetry app.

4. The target ulcer must have been present for a minimum of 4 weeks and a maximum of 52 weeks of standard of care prior to the initial screening visit.

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 full thickness on the foot or ankle that does not probe to bone.

7. Adequate circulation to the affected foot as documented by any of the following methods performed within 3 months of the first screening visit:

1. TCOM =30 mmHg

2. ABI between 0.7 and 1.3

3. PVR: Biphasic

4. TBI ?0.6

5. As an alternative arterial Doppler ultrasound can be performed evaluating for biphasic dorsalis pedis and posterior tibial vessels at the level of the ankle

8. If the 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 randomization.

10. The subject must consent to using the prescribed off-loading method for the duration of the study.

11. The subject must agree to attend the weekly study visits required by the protocol.

12. The subject must be willing and able to participate in the informed consent process.

Exclusion Criteria:

1. A subject known to have a life expectancy of < 6 months is excluded.

2. If the target ulcer is infected or if there is cellulitis in the surrounding skin, the subject is excluded.

3. Presence of osteomyelitis or exposed bone, probes to bone or joint capsule on investigator's exam or radiographic evidence.

4. A potential subject cannot have an infection in the target ulcer or in a remote location that requires systemic antibiotic therapy.

5. A subject receiving immunosuppressants (including systemic corticosteroids at doses greater than 10 mg of Prednisone per day or equivalent) or cytotoxic chemotherapy is excluded.

6. The topical application of steroids to the ulcer surface within one month of initial screening is not permitted.

7. A subject with a previous partial amputation on the affected foot is excluded if the resulting deformity impedes proper offloading of the target ulcer.

8. If a subject has a glycated hemoglobin (HbA1c) greater than or equal to 12% taken at or within 3 months of the initial screening visit he/she is excluded.

9. If a subject has a serum creatinine = 3.0mg/dL within 6 months of randomization he/she is excluded.

10. The subject is excluded if the surface area measurement of the target ulcer has reduced in size by more than 30% in the 2 weeks prior to the initial screening during the 2-week screening phase: the 2 weeks from the initial screening visit (SV1) to the TV1/randomization visit during which time the subject received SOC.

11. A subject with an acute Charcot foot, or an inactive Charcot foot, that impedes proper offloading of the target ulcer is excluded.

12. Women who are pregnant or considering becoming pregnant within the next 6 months are excluded.

13. A potential subject with end stage renal disease requiring dialysis is excluded.

14. A subject who participated in a clinical trial involving treatment with an investigational product within the previous 30 days is excluded.

15. A subject who, in the opinion of the Investigator, has a medical or psychological condition that may interfere with study assessments is excluded.

16. A subject treated with hyperbaric oxygen therapy or a Cellular and/or Tissue Product (CTP) in the 30 days prior to the initial screening visit is excluded.

Related Conditions & MeSH terms

• Diabetic Foot
• Diabetic Foot Ulcer
• Foot Ulcer
• Ulcer
• Ulcer Foot

Intervention

Device:
• Mirragen Wound Matrix
Offloading- patient will be offloaded in a diabetic CAM boot after treatment, or total contact cast if patient cannot be fit in a diabetic boot. Other names; pressure relief. Additional "outer" dressing application-application of outer moisture retentive dressing, and a multilayer compression dressing. Other names; outer protective dressing. Mirragen Wound Matrix-application of Mirragen to wound site along with standard of care treatment.
• Fibracol
Offloading- patient will be offloaded in a diabetic CAM boot after treatment, or total contact cast if patient cannot be fit in a diabetic boot. Other names; pressure relief. Additional "outer" dressing application-application of outer moisture retentive dressing, and a multilayer compression dressing. Other names; outer protective dressing. Mirragen Wound Matrix-application of Mirragen to wound site along with standard of care treatment.

Locations

Country	Name	City	State
United States	United Wound Healing P.S	Auburn	Washington
United States	Mercy Medical Center	Cedar Rapids	Iowa
United States	Wound Centrics	Corpus Christi	Texas
United States	PULSE: Amputation Prevention Center, LLC	El Paso	Texas
United States	Foot and Ankle Specialists of the Mid Atlantic	Frederick	Maryland
United States	Southernmost Foot and Ankle Specialists	Homestead	Florida
United States	Wound Care Experts	Las Vegas	Nevada
United States	LA Foot and Ankle	Los Angeles	California
United States	Gateway Clinical Trials	O'Fallon	Illinois
United States	Casa Colina	Pomona	California
United States	Foot and Ankle Specialists of the Mid Atlantic	Salem	Virginia
United States	Center for Clincal Research	San Francisco	California
United States	Doctor's Research Network	South Miami	Florida
United States	Foot and Ankle Center of Illinois	Springfield	Illinois
United States	Lower Extremity Institute for Research and Therapy	Youngstown	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
ETS Wound Care, LLC	Professional Education and Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Difference in cellulitis and/or infection	Difference in cellulitis and/or infection at 12 weeks	12 weeks
Other	Use of near-infrared tissue oxygenation imaging	Use of near-infrared tissue oxygenation imaging assessment of wounds at select sites to evaluate changes in vascularization/oxygenation of wounds with treatment (Kent Imaging SnapshotNIR: Time Frame: SV1, TV1 pre-randomization, TV2, TV4, TV7, and EOS1	12 weeks
Primary	Percentage of index ulcers healed at 12 weeks	The proportion of subjects that obtain complete closure over the 12- week treatment period	12 weeks
Secondary	Time to achieve complete wound closure	The time to achieve complete wound closure of the target ulcer by the end of 12 weeks	12 weeks
Secondary	Percent wound area reduction (PAR)	Percentage wound area reduction from TV1 to TV13 measured weekly with digital photographic planimetry and physical examination	6 and 12 weeks
Secondary	Changes in peripheral neuropathy using Semmes Weinstein Monofilament "10" point discrimination test	Each clinical trial participant will be examined by the principal investigator with a Semmes Weinstein monofilament wire at 10 points on the study foot, this standardized exam will be scored out of a total of 10 at each visit and recorded. (week 1, 3, 7, 9, 12)	12 weeks
Secondary	Changes in wound quality of life using Wound-Q	The Wound-QoL, or wound quality of life questionnaire, measures the disease-specific, health-related quality of life of patients with chronic wounds. It consists of 17 items on impairments which are always assessed in retrospect to the preceding seven days. This questionnaire will be given to clinical trial participants at each visit, with the scale scores recorded. Each question is scored. Answers to each item are coded with numbers (0='note at all' to 4='very much'). As noted above the score will be reported with a minimum score of "0" and a maximum score of 68. (week 1, 3, 7, 9, 12)	12 weeks
Secondary	Change in pain levels during trial, using the NPRS pain scale which measure pain on a range of 0-10, zero being no pain and 10 being the most severe pain	The FACES pain scale will be administered to the clinical trial participants at each visit. The trial participant will select their pain level with a series of faces that correspond to a number between 0 which implies no pain, up to 10 which implies the most severe pain. The scores will be recorded for each clinical trial participant on each visit.	12 weeks
Secondary	Number and type of SAE	The number and type of treatment emergent adverse and serious adverse events	12 weeks