The Relationship of Hemoglobin A1c and Diabetic Wound Healing

Susan Hassenbein

Status and phase: Terminated; Phase 4

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

Treatments: Drug: Bacitracin; Drug: AmeriGel®; Dietary Supplement: Vitamin C

Study type: Interventional

Funder types: Other

Identifiers

NCT01350102

IRB-35832

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 2 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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2 participants in 4 patient groups

Bacitracin wound care dressing alone

Active Comparator group

Description:

Bacitracin wound care dressing alone

Treatment:

Drug: Bacitracin

Bacitracin with Vit C

Active Comparator group

Description:

Bacitracin wound care dressing with Vitamin C supplementation

Treatment:

Dietary Supplement: Vitamin C

Drug: Bacitracin

AmeriGel® wound care dressing alone

Active Comparator group

Description:

AmeriGel® wound care dressing alone

Treatment:

Drug: AmeriGel®

AmeriGel® with Vit C

Active Comparator group

Description:

AmeriGel® wound care dressing with Vitamin C supplementation

Treatment:

Dietary Supplement: Vitamin C

Drug: AmeriGel®