Status:
COMPLETED
Evaluation of a Folic Acid Wound Treatment (FAWT) for Chronic, Early-Stage Diabetic Foot Ulcer (DFU) Healing
Lead Sponsor:
Joseph Boykin, MD
Collaborating Sponsors:
George Mason University
Central Arkansas Veterans Healthcare System
Conditions:
Diabetic Foot Ulcer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 c...
Detailed Description
This clinical study is a twelve-week single-center, randomized, double-blind evaluation of the safety and efficacy of a folic acid wound treatment (FAWT) versus Placebo in the promotion of healing of ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
December 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 24 2024
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT04723134
Start Date
December 1 2021
End Date
September 24 2024
Last Update
October 4 2024
Active Locations (1)
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1
Hunter Holmes McGuire VAMC
Richmond, Virginia, United States, 23249