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The Relationship of Hemoglobin A1c and Diabetic Wound Healing

Sponsor
Susan Hassenbein (Other)
Overall Status
Terminated
CT.gov ID
NCT01350102
Collaborator
(none)
2
Enrollment
1
Location
4
Arms
24.9
Duration (Months)
0.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

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 Design

Study Type:
Interventional
Actual Enrollment :
2 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
The Relationship of Hemoglobin A1c and Diabetic Wound Healing
Study Start Date :
Feb 1, 2012
Actual Primary Completion Date :
Mar 1, 2014
Actual Study Completion Date :
Mar 1, 2014

Arms and Interventions

Arm Intervention/Treatment
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 Names:
  • Baciguent

    		•
    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 Names:
  • Baciguent

    • 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 Names:
  • 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

    		•
    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

    • 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 Names:
  • ascorbic acid

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Hgb A1c Level [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.

    Secondary Outcome Measures

    1. Length of Time for Wound Closure [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

    2. Wound Area Measurements [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).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Susan Hassenbein, Clinical Research Associate, Milton S. Hershey Medical Center
    ClinicalTrials.gov Identifier:
    NCT01350102
    Other Study ID Numbers:
    • IRB-35832
    First Posted:
    May 9, 2011
    Last Update Posted:
    Dec 12, 2017
    Last Verified:
    Nov 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by Susan Hassenbein, Clinical Research Associate, Milton S. Hershey Medical Center
    Adult
    Additional relevant MeSH terms:
    Diabetic Foot
    Foot Ulcer
    Diabetes Mellitus
    Diabetes Mellitus, Type 2
    Diabetes Mellitus, Type 1
    Ascorbic Acid
    Bacitracin

    Study Results

    Participant Flow

    Recruitment Details Two subjects were screened and enrolled at the clinic site on 2/24/2012 and 1/14/2013.
    Pre-assignment Detail
    Arm/Group Title Bacitracin Wound Care Dressing Alone Bacitracin With Vit C AmeriGel® Wound Care Dressing Alone AmeriGel® With Vit C
    Arm/Group Description Bacitracin wound care dressing alone Bacitracin: Participants will be treated with Bacitracin to their wound until 100% wound healing, which may take up to 6 months to achieve. Hemoglobin A1c: Hemoglobin A1c levels will be performed and reviewed every three months to assess its relationship to wound healing Bacitracin wound care dressing with Vitamin C supplementation Bacitracin: Participants will be treated with Bacitracin to their wound until 100% wound healing, which may take up to 6 months to achieve. Hemoglobin A1c: Hemoglobin A1c levels will be performed and reviewed every three months to assess its relationship to wound healing 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 AmeriGel® wound care dressing alone AmeriGel®: Participants will be treated with AmeriGel® to their wound until 100% wound healing, which may take up to 6 months to achieve. Hemoglobin A1c: Hemoglobin A1c levels will be performed and reviewed every three months to assess its relationship to wound healing AmeriGel® wound care dressing with Vitamin C supplementation AmeriGel®: Participants will be treated with AmeriGel® to their wound until 100% wound healing, which may take up to 6 months to achieve. Hemoglobin A1c: Hemoglobin A1c levels will be performed and reviewed every three months to assess its relationship to wound healing 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
    Period Title: Overall Study
    STARTED 0 1 1 0
    COMPLETED 0 1 0 0
    NOT COMPLETED 0 0 1 0

    Baseline Characteristics

    Arm/Group Title Bacitracin Wound Care Dressing Alone Bacitracin With Vit C AmeriGel® Wound Care Dressing Alone AmeriGel® With Vit C Total
    Arm/Group Description Bacitracin wound care dressing alone Bacitracin: Participants will be treated with Bacitracin to their wound until 100% wound healing, which may take up to 6 months to achieve. Hemoglobin A1c: Hemoglobin A1c levels will be performed and reviewed every three months to assess its relationship to wound healing Bacitracin wound care dressing with Vitamin C supplementation Bacitracin: Participants will be treated with Bacitracin to their wound until 100% wound healing, which may take up to 6 months to achieve. Hemoglobin A1c: Hemoglobin A1c levels will be performed and reviewed every three months to assess its relationship to wound healing 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 AmeriGel® wound care dressing alone AmeriGel®: Participants will be treated with AmeriGel® to their wound until 100% wound healing, which may take up to 6 months to achieve. Hemoglobin A1c: Hemoglobin A1c levels will be performed and reviewed every three months to assess its relationship to wound healing AmeriGel® wound care dressing with Vitamin C supplementation AmeriGel®: Participants will be treated with AmeriGel® to their wound until 100% wound healing, which may take up to 6 months to achieve. Hemoglobin A1c: Hemoglobin A1c levels will be performed and reviewed every three months to assess its relationship to wound healing 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 Total of all reporting groups
    Overall Participants 0 1 1 0 2
    Age (Count of Participants)
    <=18 years
    0
    NaN
    0
    0%
    0
    0%
    0
    NaN
    0
    0%
    Between 18 and 65 years
    0
    NaN
    1
    100%
    1
    100%
    0
    NaN
    2
    100%
    >=65 years
    0
    NaN
    0
    0%
    0
    0%
    0
    NaN
    0
    0%
    Sex: Female, Male (Count of Participants)
    Female
    0
    NaN
    1
    100%
    1
    100%
    0
    NaN
    2
    100%
    Male
    0
    NaN
    0
    0%
    0
    0%
    0
    NaN
    0
    0%
    Region of Enrollment (Count of Participants)
    United States
    1
    Infinity
    1
    100%
    2
    200%

    Outcome Measures

    1. Primary Outcome
    Title Hgb A1c Level
    Description 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.
    Time Frame Patients are assessed every 3 months from enrollment through end of study participation, which may be 6 months

    Outcome Measure Data

    Analysis Population Description
    Enrollment and 3-month visit A1c levels were obtained for the subject in the Bacitracin with Vit C arm. Enrollment A1c level was obtained for the AmeriGel would care dressing alone. However, this subject withdrew from the study before 3-month A1c level was obtained.
    Arm/Group Title Bacitracin Wound Care Dressing Alone Bacitracin With Vit C AmeriGel® Wound Care Dressing Alone AmeriGel® With Vit C
    Arm/Group Description Bacitracin wound care dressing alone Bacitracin: Participants will be treated with Bacitracin to their wound until 100% wound healing, which may take up to 6 months to achieve. Hemoglobin A1c: Hemoglobin A1c levels will be performed and reviewed every three months to assess its relationship to wound healing Bacitracin wound care dressing with Vitamin C supplementation Bacitracin: Participants will be treated with Bacitracin to their wound until 100% wound healing, which may take up to 6 months to achieve. Hemoglobin A1c: Hemoglobin A1c levels will be performed and reviewed every three months to assess its relationship to wound healing 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 AmeriGel® wound care dressing alone AmeriGel®: Participants will be treated with AmeriGel® to their wound until 100% wound healing, which may take up to 6 months to achieve. Hemoglobin A1c: Hemoglobin A1c levels will be performed and reviewed every three months to assess its relationship to wound healing AmeriGel® wound care dressing with Vitamin C supplementation AmeriGel®: Participants will be treated with AmeriGel® to their wound until 100% wound healing, which may take up to 6 months to achieve. Hemoglobin A1c: Hemoglobin A1c levels will be performed and reviewed every three months to assess its relationship to wound healing 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
    Measure Participants 0 1 1 0
    Enrollment A1c
    5.2
    12.1
    3 Month A1c
    6.1
    NA
    2. Secondary Outcome
    Title Length of Time for Wound Closure
    Description Length of time for wound closure will be measured in days
    Time Frame Patients are assessed every other week (bi-weekly) until 100% wound healing is achieved, which may take up to 6 months

    Outcome Measure Data

    Analysis Population Description
    Only the subject in the Bacitracin with Vit C arm achieved would healing. The subject in the AmeriGel would care dressing alone arm was withdrawn due to lack of healing and infection.
    Arm/Group Title Bacitracin Wound Care Dressing Alone Bacitracin With Vit C AmeriGel® Wound Care Dressing Alone AmeriGel® With Vit C
    Arm/Group Description Bacitracin wound care dressing alone Bacitracin: Participants will be treated with Bacitracin to their wound until 100% wound healing, which may take up to 6 months to achieve. Hemoglobin A1c: Hemoglobin A1c levels will be performed and reviewed every three months to assess its relationship to wound healing Bacitracin wound care dressing with Vitamin C supplementation Bacitracin: Participants will be treated with Bacitracin to their wound until 100% wound healing, which may take up to 6 months to achieve. Hemoglobin A1c: Hemoglobin A1c levels will be performed and reviewed every three months to assess its relationship to wound healing 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 AmeriGel® wound care dressing alone AmeriGel®: Participants will be treated with AmeriGel® to their wound until 100% wound healing, which may take up to 6 months to achieve. Hemoglobin A1c: Hemoglobin A1c levels will be performed and reviewed every three months to assess its relationship to wound healing AmeriGel® wound care dressing with Vitamin C supplementation AmeriGel®: Participants will be treated with AmeriGel® to their wound until 100% wound healing, which may take up to 6 months to achieve. Hemoglobin A1c: Hemoglobin A1c levels will be performed and reviewed every three months to assess its relationship to wound healing 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
    Measure Participants 0 1 0 0
    Number [Days]
    141
    3. Secondary Outcome
    Title Wound Area Measurements
    Description Wound area measurements in length, width, and depth throughout the course of the study(measured in cm).
    Time Frame Patients are assessed every other week (bi-weekly) until 100% wound healing is achieved, which may take up to 6 months

    Outcome Measure Data

    Analysis Population Description
    The subject enrolled in Bacitracin with Vit C arm had measurements of the wound (width, depth, length) recorded beginning at week 0 through week 20. The subject enrolled in the AmeriGel wound care dressing alone had measurements recorded of the wound (width, depth, length) beginning at week 0 through week 2 before withdrawing from the study.
    Arm/Group Title Bacitracin Wound Care Dressing Alone Bacitracin With Vit C AmeriGel® Wound Care Dressing Alone AmeriGel® With Vit C
    Arm/Group Description Bacitracin wound care dressing alone Bacitracin: Participants will be treated with Bacitracin to their wound until 100% wound healing, which may take up to 6 months to achieve. Hemoglobin A1c: Hemoglobin A1c levels will be performed and reviewed every three months to assess its relationship to wound healing Bacitracin wound care dressing with Vitamin C supplementation Bacitracin: Participants will be treated with Bacitracin to their wound until 100% wound healing, which may take up to 6 months to achieve. Hemoglobin A1c: Hemoglobin A1c levels will be performed and reviewed every three months to assess its relationship to wound healing 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 AmeriGel® wound care dressing alone AmeriGel®: Participants will be treated with AmeriGel® to their wound until 100% wound healing, which may take up to 6 months to achieve. Hemoglobin A1c: Hemoglobin A1c levels will be performed and reviewed every three months to assess its relationship to wound healing AmeriGel® wound care dressing with Vitamin C supplementation AmeriGel®: Participants will be treated with AmeriGel® to their wound until 100% wound healing, which may take up to 6 months to achieve. Hemoglobin A1c: Hemoglobin A1c levels will be performed and reviewed every three months to assess its relationship to wound healing 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
    Measure Participants 0 1 1 0
    Week 0 Width of Wound
    0.9
    0.3
    Week 0 Depth of Wound
    0.2
    0.2
    Week 0 Length of Wound
    1.0
    2
    Week 2 Width of Wound
    0.4
    0.5
    Week 2 Depth of Wound
    0.1
    0.2
    Week 2 Length of Wound
    0.5
    0.5
    Week 4 Width of Wound
    0.4
    NA
    Week 4 Depth of Wound
    0.1
    NA
    Week 4 Length of Wound
    0.5
    NA
    Week 6 Width of Wound
    0.2
    NA
    Week 6 Depth of Wound
    0.1
    NA
    Week 6 Length of Wound
    0.2
    NA
    Week 8 Width of Wound
    0.1
    NA
    Week 8 Depth of Wound
    0.3
    NA
    Week 8 Length of Wound
    0.1
    NA
    Week 10 Width of Wound
    0.1
    NA
    Week 10 Depth of Wound
    0.1
    NA
    Week 10 Length of Wound
    0.2
    NA
    Week 12 Width of Wound
    0.1
    NA
    Week 12 Depth of Wound
    0.1
    NA
    Week 12 Length of Wound
    0.3
    NA
    Week 14 Width of Wound
    0.1
    NA
    Week 14 Depth of Wound
    0.1
    NA
    Week 14 Length of Wound
    0.3
    NA
    Week 16 Width of Wound
    0.1
    NA
    Week 16 Depth of Wound
    0.1
    NA
    Week 16 Length of Wound
    0.1
    NA
    Week 18 Width of Wound
    0.3
    NA
    Week 18 Depth of Wound
    0.1
    NA
    Week 18 Length of Wound
    0.3
    NA
    Week 20 Width of Wound
    0.0
    NA
    Week 20 Depth of Wound
    0.0
    NA
    Week 20 Length of Wound
    0.0
    NA

    Adverse Events

    Time Frame enrollment through 20 weeks
    Adverse Event Reporting Description
    Arm/Group Title Bacitracin Wound Care Dressing Alone Bacitracin With Vit C AmeriGel® Wound Care Dressing Alone AmeriGel® With Vit C
    Arm/Group Description Bacitracin wound care dressing alone Bacitracin: Participants will be treated with Bacitracin to their wound until 100% wound healing, which may take up to 6 months to achieve. Hemoglobin A1c: Hemoglobin A1c levels will be performed and reviewed every three months to assess its relationship to wound healing Bacitracin wound care dressing with Vitamin C supplementation Bacitracin: Participants will be treated with Bacitracin to their wound until 100% wound healing, which may take up to 6 months to achieve. Hemoglobin A1c: Hemoglobin A1c levels will be performed and reviewed every three months to assess its relationship to wound healing 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 AmeriGel® wound care dressing alone AmeriGel®: Participants will be treated with AmeriGel® to their wound until 100% wound healing, which may take up to 6 months to achieve. Hemoglobin A1c: Hemoglobin A1c levels will be performed and reviewed every three months to assess its relationship to wound healing AmeriGel® wound care dressing with Vitamin C supplementation AmeriGel®: Participants will be treated with AmeriGel® to their wound until 100% wound healing, which may take up to 6 months to achieve. Hemoglobin A1c: Hemoglobin A1c levels will be performed and reviewed every three months to assess its relationship to wound healing 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
    All Cause Mortality
    Bacitracin Wound Care Dressing Alone Bacitracin With Vit C AmeriGel® Wound Care Dressing Alone AmeriGel® With Vit C
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/0 (NaN) 0/1 (0%) 0/1 (0%) 0/0 (NaN)
    Serious Adverse Events
    Bacitracin Wound Care Dressing Alone Bacitracin With Vit C AmeriGel® Wound Care Dressing Alone AmeriGel® With Vit C
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/0 (NaN) 0/1 (0%) 0/1 (0%) 0/0 (NaN)
    Other (Not Including Serious) Adverse Events
    Bacitracin Wound Care Dressing Alone Bacitracin With Vit C AmeriGel® Wound Care Dressing Alone AmeriGel® With Vit C
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/0 (NaN) 0/1 (0%) 1/1 (100%) 0/0 (NaN)
    Infections and infestations
    Infection 0/0 (NaN) 0 0/1 (0%) 0 1/1 (100%) 1 0/0 (NaN) 0

    Limitations/Caveats

    Study terminated due to recruitment issues - only two subjects enrolled in study.

    More Information

    Certain Agreements

    All Principal Investigators ARE employed by the organization sponsoring the study.

    There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/Title Nell Blake, DPM
    Organization Penn State Milton S. Hershey Medical Center
    Phone (717) 531-5638
    Email nblake@pennstatehealth.psu.edu
    Responsible Party:
    Susan Hassenbein, Clinical Research Associate, Milton S. Hershey Medical Center
    ClinicalTrials.gov Identifier:
    NCT01350102
    Other Study ID Numbers:
    • IRB-35832
    First Posted:
    May 9, 2011
    Last Update Posted:
    Dec 12, 2017
    Last Verified:
    Nov 1, 2017