Wagner 1 and 2 diabetic foot ulcers (DFUs) Skin and Connective Tissue Diseases Wagner 1 and 2 diabetic foot ulcers (DFUs)
Conditions
Interventions
Randomisation is performed using envelopes that have be prepared prior to the randomisation visits.
Group 1: Standard of Care (SOC)
Group 2: SOC + mVASC. mVASC is a mi
Sponsors
Microvascular Tissues, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. At least 18 years old 2. Presence of a DFU, Wagner 1 or 2 grade, extending at least through the dermis or subcutaneous tissue and may involve the tendon, muscle, or bone, on any aspect of the foot, provided it is below the medial aspect of the malleolus 3. The index ulcer will be the largest ulcer if two or more DFUs are present with the same Wagner grade and will be the only one evaluated in the study. If other ulcerations are present on the same foot they must be more than 2 cm distant from the index ulcer 4. Index ulcer (i.e. current episode of ulceration) has been present for greater than four weeks prior to the initial screening visit and less than 1-year, as of the date subject consents for study 5. Index ulcer is a minimum of 0.75 cm2 and a maximum of 25 cm2 at first screening visit (SV1) and first treatment visit (TV1) 6. Adequate circulation to the affected foot as documented by a dorsal transcutaneous oxygen measurement (TCOM) or a skin perfusion pressure (SPP) measurement of = 30 mmHg, or an Ankle Branchial Index (ABI) between 0.7 and 1.3 within 3 months of SV1, using the affected study extremity. As an alternative arterial Doppler ultrasound can be performed evaluating for biphasic dorsalis pedis and posterior tibial vessels at the level of the ankle or a Toe Brachial Index (TBI) of > 0.6 is acceptable 7. The index ulcer has been offloaded for at least 14 days prior to randomization 8. Females of childbearing potential must be willing to use acceptable methods of contraception (birth control pills, barriers or abstinence) during the course of the study and undergo pregnancy tests 9. Subject understands and is willing to participate in the clinical study and can comply with weekly visits
Exclusion criteria
Exclusion criteria: 1. Index ulcer(s) deemed by the investigator to be caused by a medical condition other than diabetes 2. Index ulcer, in the opinion of the investigator, is suspicious for cancer and should undergo an ulcer biopsy to rule out a carcinoma of the ulcer 3. Subjects with a history of more than 2 weeks treatment with immune-suppressants (including systemic corticosteroids >10mg daily dose), cytotoxic chemotherapy or application of topical steroids to the ulcer surface within one month prior to SV1, or who receive such medications during the screening period, or who are anticipated to require such medications during the course of the study 4. Subjects taking a selective COX-2 inhibitor (e.g., celexocib) for any condition 5. Subjects on any investigational drug(s) or therapeutic device(s) within 30 days preceding SV1 6. History of radiation at the ulcer site (regardless of time since last radiation treatment) 7. Index ulcer has been previously treated or will need to be treated with any prohibited therapies. (See Section 7.3 of this protocol for a list of prohibited medications and therapies) 8. Presence of any condition(s) which seriously compromises the subject’s ability to complete this study or has a known history of poor adherence with medical treatment 9. Osteomyelitis or bone infection of the affected foot near the site of the wound as verified by X-ray within 30 days prior to randomization. (In the event of an ambiguous diagnosis, the Principal Investigator will make the final decision) 10. Subject is pregnant or breast-feeding 11. Presence of diabetes with poor metabolic control as documented with an HbA1c > 12.0 within 90 days of randomization 12. Subjects with end stage renal disease as evidenced by a serum creatinine = 3.0 mg/dL within 120 days of randomization 13. Index ulcer has reduced in area by 20% or more after 14 days of SOC from SV1 to the TV1/randomization visit
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of index ulcers healed is measured using photographs of the index ulcer at baseline and 12 weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 18/03/2021: 1. Time to heal is measured using photographs at 6 and 12 weeks 2. Percent Area Reduction (PAR) measured using photographs at 6 and 12 weeks 3. Changes in peripheral neuropathy appendage area is measured using a probe and photographs at baseline and at 12 weeks 4. Difference in cellulitis and/or infection is measured using a visual scoring system at baseline and at 12 weeks _____ Previous secondary outcome measures: 1. Percentage of index ulcers healed is measured using photographs at baseline and at 6 weeks 2. Time to heal is measured using photographs at 6 and 12 weeks 3. Percent Area Reduction (PAR) measured using photographs at 6 and 12 weeks 4. Changes in peripheral neuropathy appendage area is measured using a probe and photographs at baseline and at 12 weeks 5. Changes in wound quality of life (per W-QoL) is measured using the validated W-QofL instrument at baseline and at 12 weeks 6. Change in pain levels during trial is measured using a visual analog scale (VAS) at baseline and at 12 weeks 7. Difference in cellulitis and/or infection is measured using a visual scoring system at baseline and at 12 weeks | — |
Countries
United States of America
Contacts
Public ContactLael Pickett
Outcome results
None listed