Official Title

The Relationship of Hemoglobin A1c and Diabetic Wound Healing
  • Phase

    Phase 4
  • Study Type

    Interventional
  • Study Participants

    2
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.
Study Started
Feb 29
2012
Primary Completion
Mar 31
2014
Study Completion
Mar 31
2014
Results Posted
Dec 12
2017
Last Update
Dec 12
2017

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

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

Bacitracin wound care dressing alone Active Comparator

Bacitracin wound care dressing alone

Bacitracin with Vit C Active Comparator

Bacitracin wound care dressing with Vitamin C supplementation

AmeriGel® wound care dressing alone Active Comparator

AmeriGel® wound care dressing alone

AmeriGel® with Vit C Active Comparator

AmeriGel® wound care dressing with Vitamin C supplementation

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

Summary

Bacitracin Wound Care Dressing Alone

Bacitracin With Vit C

AmeriGel® Wound Care Dressing Alone

AmeriGel® With Vit C

All Events

Event Type Organ System Event Term Bacitracin Wound Care Dressing Alone Bacitracin With Vit C AmeriGel® Wound Care Dressing Alone AmeriGel® With Vit C

Hgb A1c Level

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.

Bacitracin Wound Care Dressing Alone

Bacitracin With Vit C

3 Month A1c

6.1
percentage of hemoglobin

Enrollment A1c

5.2
percentage of hemoglobin

AmeriGel® Wound Care Dressing Alone

3 Month A1c

Enrollment A1c

12.1
percentage of hemoglobin

AmeriGel® With Vit C

Length of Time for Wound Closure

Length of time for wound closure will be measured in days

Bacitracin Wound Care Dressing Alone

Bacitracin With Vit C

141.0
Days

AmeriGel® Wound Care Dressing Alone

AmeriGel® With Vit C

Wound Area Measurements

Wound area measurements in length, width, and depth throughout the course of the study(measured in cm).

Bacitracin Wound Care Dressing Alone

Bacitracin With Vit C

Week 0 Depth of Wound

0.2
cm

Week 0 Length of Wound

1.0
cm

Week 0 Width of Wound

0.9
cm

Week 10 Depth of Wound

0.1
cm

Week 10 Length of Wound

0.2
cm

Week 10 Width of Wound

0.1
cm

Week 12 Depth of Wound

0.1
cm

Week 12 Length of Wound

0.3
cm

Week 12 Width of Wound

0.1
cm

Week 14 Depth of Wound

0.1
cm

Week 14 Length of Wound

0.3
cm

Week 14 Width of Wound

0.1
cm

Week 16 Depth of Wound

0.1
cm

Week 16 Length of Wound

0.1
cm

Week 16 Width of Wound

0.1
cm

Week 18 Depth of Wound

0.1
cm

Week 18 Length of Wound

0.3
cm

Week 18 Width of Wound

0.3
cm

Week 20 Depth of Wound

Week 20 Length of Wound

Week 20 Width of Wound

Week 2 Depth of Wound

0.1
cm

Week 2 Length of Wound

0.5
cm

Week 2 Width of Wound

0.4
cm

Week 4 Depth of Wound

0.1
cm

Week 4 Length of Wound

0.5
cm

Week 4 Width of Wound

0.4
cm

Week 6 Depth of Wound

0.1
cm

Week 6 Length of Wound

0.2
cm

Week 6 Width of Wound

0.2
cm

Week 8 Depth of Wound

0.3
cm

Week 8 Length of Wound

0.1
cm

Week 8 Width of Wound

0.1
cm

AmeriGel® Wound Care Dressing Alone

Week 0 Depth of Wound

0.2
cm

Week 0 Length of Wound

2.0
cm

Week 0 Width of Wound

0.3
cm

Week 10 Depth of Wound

Week 10 Length of Wound

Week 10 Width of Wound

Week 12 Depth of Wound

Week 12 Length of Wound

Week 12 Width of Wound

Week 14 Depth of Wound

Week 14 Length of Wound

Week 14 Width of Wound

Week 16 Depth of Wound

Week 16 Length of Wound

Week 16 Width of Wound

Week 18 Depth of Wound

Week 18 Length of Wound

Week 18 Width of Wound

Week 20 Depth of Wound

Week 20 Length of Wound

Week 20 Width of Wound

Week 2 Depth of Wound

0.2
cm

Week 2 Length of Wound

0.5
cm

Week 2 Width of Wound

0.5
cm

Week 4 Depth of Wound

Week 4 Length of Wound

Week 4 Width of Wound

Week 6 Depth of Wound

Week 6 Length of Wound

Week 6 Width of Wound

Week 8 Depth of Wound

Week 8 Length of Wound

Week 8 Width of Wound

AmeriGel® With Vit C

Total

2
Participants

Age, Categorical

Region of Enrollment

Sex: Female, Male

Overall Study

Bacitracin With Vit C

AmeriGel® Wound Care Dressing Alone

Drop/Withdrawal Reasons

AmeriGel® Wound Care Dressing Alone