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The Relationship of Hemoglobin A1c and Diabetic Wound Healing

Information source: Milton S. Hershey Medical Center
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Diabetes, Type 1; Diabetes, Type 2; Foot Ulcer, Diabetic

Intervention: Bacitracin (Drug); AmeriGel® (Drug); Hemoglobin A1c (Procedure); Vitamin C (Dietary Supplement)

Phase: Phase 4

Status: Terminated

Sponsored by: Susan Hassenbein

Official(s) and/or principal investigator(s):
Nell V. Blake, DPM, Principal Investigator, Affiliation: Milton S. Hershey Medical Center


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.

Clinical Details

Official title: The Relationship of Hemoglobin A1c and Diabetic Wound Healing

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Wound healing

Detailed 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.


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


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,


- 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


Locations and Contacts

Penn State Milton S. Hershey Medical Center, Hershey, Pennsylvania 17033, United States
Additional Information

Related publications:

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Jensen JL, Seeley J, Gillin B. Diabetic foot ulcerations. A controlled, randomized comparison of two moist wound healing protocols: Carrasyn Hydrogel Wound dressing and wet-to-moist saline gauze. Adv Wound Care. 1998 Nov-Dec;11(7 Suppl):1-4.

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Starting date: February 2012
Last updated: May 6, 2015

Page last updated: August 20, 2015

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