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

NCT04723134 | Completed Phase 2 FDA Drug

• 1 other identifier: DFU/FAWT-001(8)
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Diabetic Foot Ulcer

Keywords

Wound Healing; Folic Acid; DNA Methylation

Outcome Measures

Primary Outcomes (2)

• Measures of Wound Closure (actual and percentage)

  Reduction of study wound areas

  12 weeks

• Number of Wounds with Complete Healing

  Wounds with complete re-epithelialization

  12 weeks

Study Arms (2)

Folic Acid Wound Treatment

ACTIVE COMPARATOR

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.

Combination Product: Folinic acid calcium salt

Placebo

PLACEBO COMPARATOR

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.

Combination Product: Folinic acid calcium salt

Interventions

Folinic acid calcium salt COMBINATION_PRODUCT

Folinic acid (2.5%) by combination with Placebo

Also known as: Placebo, PluroGel Burn and Wound Dressing

Folic Acid Wound Treatment; Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Joseph Boykin, MD: lead
• George Mason University: collaborator
• Central Arkansas Veterans Healthcare System: collaborator

Study Sites (1)

Hunter Holmes McGuire VAMC

Richmond, Virginia, 23249, United States

Location

MeSH Terms

Conditions

Diabetic Foot

Interventions

Bandages

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Study Officials

• Joseph V Boykin, MD

  Hunter Holmes McGuire VAMC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Medical Director, Wound Healing Program

Study Record Dates

• First Submitted: January 20, 2021
• First Posted: January 25, 2021
• Study Start: December 1, 2021
• Primary Completion: September 24, 2024
• Study Completion: September 24, 2024
• Last Updated: October 4, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)