The Relationship of Hemoglobin A1c and Diabetic Wound Healing

November 13, 2017 updated by: Susan Hassenbein
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.

Study Overview

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.

Study Type

Interventional

Enrollment (Actual)

2

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Bacitracin wound care dressing alone
Participants will be treated with Bacitracin to their wound until 100% wound healing, which may take up to 6 months to achieve.
Other Names:
  • Baciguent
Active Comparator: Bacitracin with Vit C
Bacitracin wound care dressing with Vitamin C supplementation
Participants will be treated with Bacitracin to their wound until 100% wound healing, which may take up to 6 months to achieve.
Other Names:
  • Baciguent
Participants will be treated with Vitamin C supplements 1000 mg daily until 100% wound healing, which may take up to 6 months to achieve
Other Names:
  • ascorbic acid
Active Comparator: AmeriGel® wound care dressing alone
Participants will be treated with AmeriGel® to their wound until 100% wound healing, which may take up to 6 months to achieve.
Other Names:
  • Oakin®-based hydrogel
  • hydrogel containing Oakin®
  • Oak extract
Active Comparator: AmeriGel® with Vit C
AmeriGel® wound care dressing with Vitamin C supplementation
Participants will be treated with Vitamin C supplements 1000 mg daily until 100% wound healing, which may take up to 6 months to achieve
Other Names:
  • ascorbic acid
Participants will be treated with AmeriGel® to their wound until 100% wound healing, which may take up to 6 months to achieve.
Other Names:
  • Oakin®-based hydrogel
  • hydrogel containing Oakin®
  • Oak extract

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hgb A1c Level
Time Frame: Patients are assessed every 3 months from enrollment through end of study participation, which may be 6 months
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
Time Frame: Patients are assessed every other week (bi-weekly) until 100% wound healing is achieved, which may take up to 6 months
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
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 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Nell V. Blake, DPM, Milton S. Hershey Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2012

Primary Completion (Actual)

March 1, 2014

Study Completion (Actual)

March 1, 2014

Study Registration Dates

First Submitted

May 4, 2011

First Submitted That Met QC Criteria

May 6, 2011

First Posted (Estimate)

May 9, 2011

Study Record Updates

Last Update Posted (Actual)

December 12, 2017

Last Update Submitted That Met QC Criteria

November 13, 2017

Last Verified

November 1, 2017

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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