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The Relationship of Hemoglobin A1c and Diabetic Wound Healing

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ClinicalTrials.gov Identifier: NCT01350102
Recruitment Status : Terminated (study closed due to recruitment problems)
First Posted : May 9, 2011
Results First Posted : December 12, 2017
Last Update Posted : December 12, 2017
Sponsor:
Information provided by (Responsible Party):
Susan Hassenbein, Milton S. Hershey Medical Center

May 4, 2011
May 9, 2011
June 28, 2017
December 12, 2017
December 12, 2017
February 2012
March 2014   (Final data collection date for primary outcome measure)
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.
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 ]
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 levels will be drawn at enrollment and at three month intervals. Wound healing may take up to 6 months.
Complete list of historical versions of study NCT01350102 on ClinicalTrials.gov Archive Site
  • 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
  • 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).
Not Provided
Not Provided
Not Provided
 
The Relationship of Hemoglobin A1c and Diabetic Wound Healing
The Relationship of Hemoglobin A1c and Diabetic Wound Healing
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.
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.
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Diabetes, Type 1
  • Diabetes, Type 2
  • Foot Ulcer, Diabetic
  • 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
  • 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
  • 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: Bacitracin wound care dressing alone
    Bacitracin wound care dressing alone
    Intervention: Drug: Bacitracin
  • Active Comparator: Bacitracin with Vit C
    Bacitracin wound care dressing with Vitamin C supplementation
    Interventions:
    • Drug: Bacitracin
    • Dietary Supplement: Vitamin C
  • Active Comparator: AmeriGel® wound care dressing alone
    AmeriGel® wound care dressing alone
    Intervention: Drug: AmeriGel®
  • Active Comparator: AmeriGel® with Vit C
    AmeriGel® wound care dressing with Vitamin C supplementation
    Interventions:
    • Drug: AmeriGel®
    • Dietary Supplement: Vitamin C

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
2
32
March 2014
March 2014   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01350102
IRB-35832
No
Not Provided
Plan to Share IPD: No
Susan Hassenbein, Milton S. Hershey Medical Center
Susan Hassenbein
Not Provided
Principal Investigator: Nell V. Blake, DPM Milton S. Hershey Medical Center
Milton S. Hershey Medical Center
November 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP