The Relationship of Hemoglobin A1c and Diabetic Wound Healing

Study Overview
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Brief Summary
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The 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.

Detailed Description
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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.

Official Title
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The Relationship of Hemoglobin A1c and Diabetic Wound Healing

Conditions
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Diabetes, Type 1, Diabetes, Type 2, Foot Ulcer, Diabetic

Intervention / Treatment
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* Drug: Bacitracin
* Drug: AmeriGel®
* Dietary Supplement: Vitamin C


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Bacitracin wound care dressing alone<br>Bacitracin wound care dressing alone | Drug: Bacitracin<br>* Participants will be treated with Bacitracin to their wound until 100% wound healing, which may take up to 6 months to achieve.<br>* Other names: Baciguent;|
| Active Comparator: Bacitracin with Vit C<br>Bacitracin wound care dressing with Vitamin C supplementation | Drug: Bacitracin<br>* Participants will be treated with Bacitracin to their wound until 100% wound healing, which may take up to 6 months to achieve.<br>* Other names: Baciguent;Dietary Supplement: Vitamin C<br>* Participants will be treated with Vitamin C supplements 1000 mg daily until 100% wound healing, which may take up to 6 months to achieve<br>* Other names: ascorbic acid;|
| Active Comparator: AmeriGel® wound care dressing alone<br>AmeriGel® wound care dressing alone | Drug: AmeriGel®<br>* Participants will be treated with AmeriGel® to their wound until 100% wound healing, which may take up to 6 months to achieve.<br>* Other names: Oak extract;|
| Active Comparator: AmeriGel® with Vit C<br>AmeriGel® wound care dressing with Vitamin C supplementation | Drug: AmeriGel®<br>* Participants will be treated with AmeriGel® to their wound until 100% wound healing, which may take up to 6 months to achieve.<br>* Other names: Oak extract;Dietary Supplement: Vitamin C<br>* Participants will be treated with Vitamin C supplements 1000 mg daily until 100% wound healing, which may take up to 6 months to achieve<br>* Other names: ascorbic acid;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hgb A1c Level | 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. | Patients are assessed every 3 months from enrollment through end of study participation, which may be 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of Time for Wound Closure | Length of time for wound closure will be measured in days | Patients are assessed every other week (bi-weekly) until 100% wound healing is achieved, which may take up to 6 months | 
| Wound Area Measurements | Wound area measurements in length, width, and depth throughout the course of the study(measured in cm). | Patients are assessed every other week (bi-weekly) until 100% wound healing is achieved, which may take up to 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Adult