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Vitamin

Folic Acid for Diabetic Foot Ulcers

Phase 2
Recruiting
Led By Joseph V Boykin, MD
Research Sponsored by Joseph Boykin, MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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.
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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights

Study Summary

This trial will compare the safety and effectiveness of a folic acid treatment to a placebo in healing chronic early-stage diabetic foot ulcers. The study will enroll male and female veterans with type-2 diabetes mellitus.

Who is the study for?
Veterans with type-2 diabetes and chronic early-stage diabetic foot ulcers (ES-DFU) are eligible for this trial. They must have a non-healing wound for at least four weeks, without acute infection or cancerous lesions. Women of childbearing age should use birth control and not be pregnant or breastfeeding. Participants cannot have used certain treatments like high-dose folic acid or hyperbaric oxygen therapy recently.Check my eligibility
What is being tested?
The study is testing the safety and effectiveness of a folic acid wound treatment (FAWT) compared to a placebo in healing diabetic foot ulcers over twelve weeks. It's randomized, meaning participants are put into groups by chance, double-blind so neither they nor the researchers know who gets FAWT or placebo.See study design
What are the potential side effects?
While specific side effects aren't listed here, typical concerns may include skin irritation at the application site, allergic reactions to ingredients in the treatment, or no improvement in ulcer healing.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have a non-healing foot ulcer for over 4 weeks, not too deep, sized 1-12cm2, without severe infection.
Select...
I am a veteran with type 2 diabetes and a chronic, non-healing wound for at least 4 weeks.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Measures of Wound Closure (actual and percentage)
Number of Wounds with Complete Healing

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Folic Acid Wound TreatmentActive Control1 Intervention
Intervention - participants receiving 2.5% folinic acid wound treatment for daily treatment of chronic early stage diabetic foot ulcer wound. This will be applied daily to the study wound selected for monitoring.
Group II: PlaceboPlacebo Group1 Intervention
Intervention - participants receiving Placebo (PluroGel Burn and Wound Dressing) for daily treatment of chronic early stage diabetic foot ulcer wound. This will be applied daily to the study wound selected for monitoring.

Find a Location

Who is running the clinical trial?

George Mason UniversityOTHER
58 Previous Clinical Trials
48,764 Total Patients Enrolled
Joseph Boykin, MDLead Sponsor
Central Arkansas Veterans Healthcare SystemFED
23 Previous Clinical Trials
3,510 Total Patients Enrolled

Media Library

Folic Acid Wound Treatment (FAWT) (Vitamin) Clinical Trial Eligibility Overview. Trial Name: NCT04723134 — Phase 2
Foot Ulcer Research Study Groups: Placebo, Folic Acid Wound Treatment
Foot Ulcer Clinical Trial 2023: Folic Acid Wound Treatment (FAWT) Highlights & Side Effects. Trial Name: NCT04723134 — Phase 2
Folic Acid Wound Treatment (FAWT) (Vitamin) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04723134 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are some common ailments that Folic Acid Wound Treatment can help with?

"This medication, folic acid, can be used to improve kidney function and help with osteodystrophy. Additionally, it is sometimes prescribed to patients that need extra joint or mineral support."

Answered by AI

Are we still able to enroll new people in this trial?

"According to the listing on clinicaltrials.gov, this study is still recruiting patients. The trial was initially posted on December 1st, 2021 and received its last update October 12th, 2022. So far, 30 people have signed up at the single location where the trial is taking place."

Answered by AI

How many candidates are being enrolled in this test program?

"That is correct, the information available on clinicaltrials.gov demonstrates that this study is still actively seeking patients. This trial was first posted on December 1st, 2021 and has been edited as recently as October 12th, 2022. They are hoping to recruit 30 people total from a single site."

Answered by AI

Has the FDA given their blessing to using Folic Acid for treating wounds?

"While there is some evidence that this folic acid wound treatment is safe, it only received a score of 2 because there is no data currently supporting its efficacy."

Answered by AI

What does the research say about using Folic Acid to help heal wounds?

"Currently, there are 296 ongoing research studies into the efficacy of folic acid for wound treatment. Of these trials, 90 are in their third and final phase. The majority of these experiments are based in Woolloongabba, Queensland; however, there 16163 total locations running similar tests worldwide."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Evaluation of a Folic Acid Wound Treatment (FAWT) for Chronic, Early-Stage Diabetic Foot Ulcer (DFU) Healing
Joseph Boykin, MD 2021. "Evaluation of a Folic Acid Wound Treatment (FAWT) for Chronic, Early-Stage Diabetic Foot Ulcer (DFU) Healing". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04723134.
~9 spots leftby Apr 2025
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