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The Relationship of Hemoglobin A1c and Diabetic Wound Healing

This study has been terminated.
(study closed due to recruitment problems)
Sponsor:
Information provided by (Responsible Party):
Susan Hassenbein, Penn State Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier:
NCT01350102
First received: May 4, 2011
Last updated: March 26, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Diabetes, Type 1
Diabetes, Type 2
Foot Ulcer, Diabetic
Drug: Bacitracin
Drug: AmeriGel®
Procedure: Hemoglobin A1c
Dietary Supplement: Vitamin C
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Relationship of Hemoglobin A1c and Diabetic Wound Healing

Resource links provided by NLM:


Further study details as provided by Milton S. Hershey Medical Center:

Primary Outcome Measures:
  • Wound healing [ Time Frame: Patients are assessed every other week (bi-weekly) until 100% wound healing is achieved, which may take up to 6 months ] [ Designated as safety issue: No ]
    Assessment of wound healing will be assessed on a biweekly basis. Healing will be defined as 100% wound re-epithelialization or wound closure. Wounds will be measured in regard to width and depth, digital images taken, and the wound assessed according to standard wound descriptors at each visit until 100% wound healing. The wound will also be given a Wagner classification. Patients will record dressing application, non-weight bearing status, and vitamin C consumption. Hgb A1c and vitamin C levels will be drawn at enrollment and at three month intervals. Wound healing may take up to 6 months.


Enrollment: 2
Study Start Date: February 2012
Study Completion Date: March 2014
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Bacitracin wound care dressing alone
Bacitracin wound care dressing alone
Drug: Bacitracin
Participants will be treated with Bacitracin to their wound until 100% wound healing, which may take up to 6 months to achieve.
Other Name: Baciguent
Procedure: Hemoglobin A1c
Hemoglobin A1c levels will be performed and reviewed every three months to assess its relationship to wound healing
Active Comparator: Bacitracin with Vit C
Bacitracin wound care dressing with Vitamin C supplementation
Drug: Bacitracin
Participants will be treated with Bacitracin to their wound until 100% wound healing, which may take up to 6 months to achieve.
Other Name: Baciguent
Procedure: Hemoglobin A1c
Hemoglobin A1c levels will be performed and reviewed every three months to assess its relationship to wound healing
Dietary Supplement: Vitamin C
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 Name: ascorbic acid
Active Comparator: AmeriGel® wound care dressing alone
AmeriGel® wound care dressing alone
Drug: AmeriGel®
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
Procedure: Hemoglobin A1c
Hemoglobin A1c levels will be performed and reviewed every three months to assess its relationship to wound healing
Active Comparator: AmeriGel® with Vit C
AmeriGel® wound care dressing with Vitamin C supplementation
Drug: AmeriGel®
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
Procedure: Hemoglobin A1c
Hemoglobin A1c levels will be performed and reviewed every three months to assess its relationship to wound healing
Dietary Supplement: Vitamin C
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 Name: ascorbic acid

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01350102

Locations
United States, Pennsylvania
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
Sponsors and Collaborators
Susan Hassenbein
Investigators
Principal Investigator: Nell V. Blake, DPM Milton S. Hershey Medical Center
  More Information

Publications:

Responsible Party: Susan Hassenbein, Clinical Research Associate, Penn State Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier: NCT01350102     History of Changes
Other Study ID Numbers: IRB-35832
Study First Received: May 4, 2011
Last Updated: March 26, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Milton S. Hershey Medical Center:
Adult

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Diabetic Foot
Foot Ulcer
Cardiovascular Diseases
Diabetes Complications
Diabetic Angiopathies
Diabetic Neuropathies
Endocrine System Diseases
Foot Diseases
Glucose Metabolism Disorders
Leg Ulcer
Metabolic Diseases
Skin Diseases
Skin Ulcer
Vascular Diseases
Ascorbic Acid
Bacitracin
Vitamins
Anti-Bacterial Agents
Anti-Infective Agents
Anti-Infective Agents, Local
Antioxidants
Growth Substances
Micronutrients
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014