Evaluation of a Folic Acid Wound Treatment (FAWT) for Chronic, Early-Stage Diabetic Foot Ulcer (DFU) Healing

Completed · Phase 2 · Has a placebo group

Conditions studied: Diabetic Foot Ulcer

In brief

This is a twelve-week single-center, randomized, double-blind, clinical study to evaluate the safety and efficacy of a folic acid wound treatment (FAWT) versus Placebo in the promotion of healing of chronic, early stage diabetic foot ulcer (ES-DFU) wounds. Male and female Veterans with type-2 diabetes mellitus and chronic ES-DFUs acceptable to the study inclusion/exclusion criteria will be considered for enrollment.

Key facts

Study ID

NCT04723134

Run by

Joseph Boykin, MD

People needed

15

Starts

2021-12-01

Expected to finish

2024-09-24

Last updated by the study team

2024-10-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Study subjects will be male or female Veterans with T2DM managed with insulin and/or non-insulin therapy who have a chronic, non-healing DFU (wound age: at least 4-weeks) and who have signed an Institutional Review Board approved informed consent document.
• Study subject candidates (SC) - may present with multiple DFUs; however, only one DFU per SC will be selected for study. A DFU-SC must be observed with: 1) at least a four-week history of a non-healing, superficial DFU-wound; PEDIS-Grade 1 or 2 Depth (wound above fascia without exposed muscle, tendon or bone); 2) DFU-wound area between 1-12cm2; 3) DFU-wound with or without clinical neuropathy; 4) DFU-wound lower extremity non-invasive Doppler studies with ankle-brachial index value ≥0.7 and/or Toe pressure ≥50mmHg; and, 5) without evidence of acute infection (e.g., cellulitis, abscess or osteomyelitis) at the time of enrollment.
• If the subject is a woman of childbearing potential she must be practicing an acceptable form of birth control, as determined by the Investigator. All females with an intact uterus must have a negative Beta-Human Chorionic Gonadotropin test (< 5mIU/mL) to proceed with study participation.

You may not qualify if…

• Any SC who is unable to provide written informed consent will not be enrolled for study participation.
• Any SC who is pregnant or breast feeding, will not be allowed to enroll, or continue, in the study, as pregnancy or breast feeding may impact the study results.
• Subjects with DFU-wounds less than 1cm-square or greater than 12cm-square will be excluded from the study.
• At the beginning of the four-week Screening Phase all SC will be scheduled for study-selected standard DFU wound treatment and off-loading of the study ulcer, as determined by the PI. Subject candidates who are unable to comply with the recommended off-loading of the selected DFU-study wound will be excluded from study.
• During the Screening Phase, any SC whose DFU wound demonstrates more than a fifty-percent (50%) reduction in wound area will be excluded from the study [37].
• Any SC with a current active history of alcohol or substance abuse will be excluded from study participation.
• Any SC receiving steroid therapy (prednisone), chemotherapy or biological therapies (e.g., Humira) within twelve-weeks will be excluded.
• Any SC with active cancerous lesions, with or without chemotherapy, will be excluded from study participation.
• Any SC having received hyperbaric oxygen therapy (HBOT) or the use of bioengineered skin substitutes (i.e., Dermagraft® or Apligraf®) within six-months will be excluded from study participation.
• Any SC receiving platelet-derived growth factor therapy (Regranex®, Ortho- McNeil) within six-months will be excluded from study participation.
• Any SC who is on dialysis (hemo- or peritoneal dialysis) or has end stage renal disease will be excluded from study participation.
• A SC with ABI values <0.7 or toe pressure <50mmHg, for the involved lower extremity of the study DFU-wound, will be excluded from study participation.
• A SC with a HgbA1C >9 will be excluded from study participation.
• Any SC with a medical condition, which, in the opinion of the investigator should exclude him/her from participating in the study.
• Any SC previously taking daily oral high-dose folic acid with B-vitamin supplements (HDFA; folic acid-5mg/cyanocobalamin- 4mg/pyridoxine-50mg) for DFU-wound treatment will not be considered for study participation until at least 28-days following the discontinuation of HDFA administration.

Where it is running

• Hunter Holmes McGuire VAMC — Richmond, Virginia, United States

Full record on ClinicalTrials.gov

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