Official Title
The Relationship of Hemoglobin A1c and Diabetic Wound Healing
Phase
Phase 4Lead Sponsor
Milton S. Hershey Medical CenterStudy Type
InterventionalStatus
Terminated Results PostedIndication/Condition
Diabetes, Type 1 Diabetes, Type 2 Foot Ulcer, DiabeticIntervention/Treatment
oak extract hemoglobin vitamin c bacitracin ...Study Participants
2The purpose of this study is to investigate the relationship of hemoglobin A1c in diabetic wound healing. Additionally, a comparison of two wound dressings, AmeriGel® (Amerx Health Care Corp., Clearwater, FL) and Bacitracin, with and without vitamin C supplementation, will be done to evaluate impact on time to wound closure.
This is a prospective randomized controlled study evaluating the relationship of hemoglobin A1c in diabetic wound healing. Length of time for wound closure will be compared using four treatment options.
Participants will be treated with Bacitracin to their wound until 100% wound healing, which may take up to 6 months to achieve.
Participants will be treated with AmeriGel® to their wound until 100% wound healing, which may take up to 6 months to achieve.
Participants will be treated with Vitamin C supplements 1000 mg daily until 100% wound healing, which may take up to 6 months to achieve
Bacitracin wound care dressing alone
Bacitracin wound care dressing with Vitamin C supplementation
AmeriGel® wound care dressing alone
Inclusion Criteria: >18 years of age Diabetic (Type I and Type II) Ulceration of the foot at least one centimeter in width/length Ulceration at least 0.2 centimeters in depth Exclusion Criteria: Ulceration width/length > 7.5 centimeters Wound depth > 1.25 centimeters Purulent, excessive drainage and/or other signs of infection (i.e. erythema, edema, warmth) Inability to provide informed consent Inability to swallow pills (vitamin C supplement) Patients with concurrent renal problems Patients with medication contraindications to Vitamin C and/or topical wound dressings
| Event Type | Organ System | Event Term | Bacitracin Wound Care Dressing Alone | Bacitracin With Vit C | AmeriGel® Wound Care Dressing Alone | AmeriGel® With Vit C |
|---|
Hgb A1c measures the average blood glucose over three months (% of hemoglobin). All subjects will be asked to get their hemoglobin A1c level at the beginning of the study and every three months for as long as they participate in the study.
Length of time for wound closure will be measured in days
Wound area measurements in length, width, and depth throughout the course of the study(measured in cm).
