The Relationship of Hemoglobin A1c and Diabetic Wound Healing

Phase 4TerminatedNCT01350102

Susan Hassenbein2 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

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

Interventions

BacitracinDRUG

Participants will be treated with Bacitracin to their wound until 100% wound healing, which may take up to 6 months to achieve.

AmeriGel®DRUG

Participants will be treated with AmeriGel® to their wound until 100% wound healing, which may take up to 6 months to achieve.

Vitamin CDIETARY_SUPPLEMENT

Participants will be treated with Vitamin C supplements 1000 mg daily until 100% wound healing, which may take up to 6 months to achieve

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, United States

Outcomes

Primary Outcomes

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.

Time frame: Patients are assessed every 3 months from enrollment through end of study participation, which may be 6 months

Secondary Outcomes

Length of Time for Wound Closure

Length of time for wound closure will be measured in days

Time frame: 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).

Time frame: Patients are assessed every other week (bi-weekly) until 100% wound healing is achieved, which may take up to 6 months

Data from ClinicalTrials.gov

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