Clinical trial NCT01350102: The Relationship of Hemoglobin A1c and Diabetic Wound Healing
Official title: The Relationship of Hemoglobin A1c and Diabetic Wound Healing
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Diabetes, Type 1
Diabetes, Type 2
Foot Ulcer, Diabetic
Keywords: Adult
Lead sponsor: Milton S. Hershey Medical Center
Sponsor class: OTHER
First posted: 2011-05-09
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Hgb A1c Level
timeFrame: Patients are assessed every 3 months from enrollment through end of study participation, which may be 6 months
Secondary outcomes:
measure: Length of Time for Wound Closure
timeFrame: Patients are assessed every other week (bi-weekly) until 100% wound healing is achieved, which may take up to 6 months
measure: Wound Area Measurements
timeFrame: Patients are assessed every other week (bi-weekly) until 100% wound healing is achieved, which may take up to 6 months
Other outcomes:
Locations:
city: Hershey
country: United States
facility: Penn State Milton S. Hershey Medical Center
state: Pennsylvania
Study officials:
affiliation: Milton S. Hershey Medical Center
name: Nell V. Blake, DPM
role: PRINCIPAL_INVESTIGATOR
References:
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