Diabetes, Type 1, Diabetes, Type 2, Foot Ulcer, Diabetic
Conditions
Keywords
Adult
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.
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.
Interventions
DRUGAmeriGel®
Participants will be treated with AmeriGel® to their wound until 100% wound healing, which may take up to 6 months to achieve.
DIETARY_SUPPLEMENTVitamin 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
DRUGBacitracin
Participants will be treated with Bacitracin to their wound until 100% wound healing, which may take up to 6 months to achieve.
Sponsors
Susan Hassenbein
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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). |
Countries
United States
Participant flow
Recruitment details
Two subjects were screened and enrolled at the clinic site on 2/24/2012 and 1/14/2013.
Participants by arm
| Arm | Count |
|---|---|
| Bacitracin Wound Care Dressing Alone 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 | 0 |
| Bacitracin With Vit C 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 | 1 |
| AmeriGel® Wound Care Dressing Alone 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 | 1 |
| AmeriGel® With Vit C 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 | 0 |
| Total | 2 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 0 | 1 | 0 |
Baseline characteristics
| Characteristic | Bacitracin Wound Care Dressing Alone | Bacitracin With Vit C | AmeriGel® Wound Care Dressing Alone | AmeriGel® With Vit C | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 2 Participants |
| Region of Enrollment United States | — | 1 Participants | 1 Participants | — | 2 Participants |
| Sex: Female, Male Female | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 2 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 1 | 0 / 1 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 1 | 1 / 1 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 1 | 0 / 1 | 0 / 0 |
Outcome results
Primary
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.
Time frame: Patients are assessed every 3 months from enrollment through end of study participation, which may be 6 months
Population: 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 | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Bacitracin With Vit C | Hgb A1c Level | Enrollment A1c | 5.2 percentage of hemoglobin |
| Bacitracin With Vit C | Hgb A1c Level | 3 Month A1c | 6.1 percentage of hemoglobin |
| AmeriGel® Wound Care Dressing Alone | Hgb A1c Level | Enrollment A1c | 12.1 percentage of hemoglobin |
| AmeriGel® Wound Care Dressing Alone | Hgb A1c Level | 3 Month A1c | NA percentage of hemoglobin |
Secondary
Length of Time for Wound Closure
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
Population: 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 | Measure | Value (NUMBER) |
|---|---|---|
| Bacitracin With Vit C | Length of Time for Wound Closure | 141 Days |
Secondary
Wound Area Measurements
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
Population: 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 | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Bacitracin With Vit C | Wound Area Measurements | Week 10 Width of Wound | 0.1 cm |
| Bacitracin With Vit C | Wound Area Measurements | Week 2 Length of Wound | 0.5 cm |
| Bacitracin With Vit C | Wound Area Measurements | Week 10 Depth of Wound | 0.1 cm |
| Bacitracin With Vit C | Wound Area Measurements | Week 0 Depth of Wound | 0.2 cm |
| Bacitracin With Vit C | Wound Area Measurements | Week 4 Width of Wound | 0.4 cm |
| Bacitracin With Vit C | Wound Area Measurements | Week 12 Width of Wound | 0.1 cm |
| Bacitracin With Vit C | Wound Area Measurements | Week 20 Depth of Wound | 0.0 cm |
| Bacitracin With Vit C | Wound Area Measurements | Week 12 Depth of Wound | 0.1 cm |
| Bacitracin With Vit C | Wound Area Measurements | Week 4 Depth of Wound | 0.1 cm |
| Bacitracin With Vit C | Wound Area Measurements | Week 12 Length of Wound | 0.3 cm |
| Bacitracin With Vit C | Wound Area Measurements | Week 0 Length of Wound | 1.0 cm |
| Bacitracin With Vit C | Wound Area Measurements | Week 14 Width of Wound | 0.1 cm |
| Bacitracin With Vit C | Wound Area Measurements | Week 4 Length of Wound | 0.5 cm |
| Bacitracin With Vit C | Wound Area Measurements | Week 14 Depth of Wound | 0.1 cm |
| Bacitracin With Vit C | Wound Area Measurements | Week 8 Length of Wound | 0.1 cm |
| Bacitracin With Vit C | Wound Area Measurements | Week 14 Length of Wound | 0.3 cm |
| Bacitracin With Vit C | Wound Area Measurements | Week 6 Width of Wound | 0.2 cm |
| Bacitracin With Vit C | Wound Area Measurements | Week 16 Width of Wound | 0.1 cm |
| Bacitracin With Vit C | Wound Area Measurements | Week 2 Width of Wound | 0.4 cm |
| Bacitracin With Vit C | Wound Area Measurements | Week 16 Depth of Wound | 0.1 cm |
| Bacitracin With Vit C | Wound Area Measurements | Week 6 Depth of Wound | 0.1 cm |
| Bacitracin With Vit C | Wound Area Measurements | Week 16 Length of Wound | 0.1 cm |
| Bacitracin With Vit C | Wound Area Measurements | Week 0 Width of Wound | 0.9 cm |
| Bacitracin With Vit C | Wound Area Measurements | Week 18 Width of Wound | 0.3 cm |
| Bacitracin With Vit C | Wound Area Measurements | Week 6 Length of Wound | 0.2 cm |
| Bacitracin With Vit C | Wound Area Measurements | Week 18 Depth of Wound | 0.1 cm |
| Bacitracin With Vit C | Wound Area Measurements | Week 2 Depth of Wound | 0.1 cm |
| Bacitracin With Vit C | Wound Area Measurements | Week 18 Length of Wound | 0.3 cm |
| Bacitracin With Vit C | Wound Area Measurements | Week 8 Width of Wound | 0.1 cm |
| Bacitracin With Vit C | Wound Area Measurements | Week 20 Width of Wound | 0.0 cm |
| Bacitracin With Vit C | Wound Area Measurements | Week 10 Length of Wound | 0.2 cm |
| Bacitracin With Vit C | Wound Area Measurements | Week 20 Length of Wound | 0.0 cm |
| Bacitracin With Vit C | Wound Area Measurements | Week 8 Depth of Wound | 0.3 cm |
| AmeriGel® Wound Care Dressing Alone | Wound Area Measurements | Week 20 Length of Wound | NA cm |
| AmeriGel® Wound Care Dressing Alone | Wound Area Measurements | Week 8 Length of Wound | NA cm |
| AmeriGel® Wound Care Dressing Alone | Wound Area Measurements | Week 20 Depth of Wound | NA cm |
| AmeriGel® Wound Care Dressing Alone | Wound Area Measurements | Week 0 Width of Wound | 0.3 cm |
| AmeriGel® Wound Care Dressing Alone | Wound Area Measurements | Week 0 Depth of Wound | 0.2 cm |
| AmeriGel® Wound Care Dressing Alone | Wound Area Measurements | Week 0 Length of Wound | 2 cm |
| AmeriGel® Wound Care Dressing Alone | Wound Area Measurements | Week 2 Width of Wound | 0.5 cm |
| AmeriGel® Wound Care Dressing Alone | Wound Area Measurements | Week 2 Depth of Wound | 0.2 cm |
| AmeriGel® Wound Care Dressing Alone | Wound Area Measurements | Week 2 Length of Wound | 0.5 cm |
| AmeriGel® Wound Care Dressing Alone | Wound Area Measurements | Week 4 Width of Wound | NA cm |
| AmeriGel® Wound Care Dressing Alone | Wound Area Measurements | Week 4 Depth of Wound | NA cm |
| AmeriGel® Wound Care Dressing Alone | Wound Area Measurements | Week 4 Length of Wound | NA cm |
| AmeriGel® Wound Care Dressing Alone | Wound Area Measurements | Week 6 Width of Wound | NA cm |
| AmeriGel® Wound Care Dressing Alone | Wound Area Measurements | Week 6 Depth of Wound | NA cm |
| AmeriGel® Wound Care Dressing Alone | Wound Area Measurements | Week 6 Length of Wound | NA cm |
| AmeriGel® Wound Care Dressing Alone | Wound Area Measurements | Week 8 Width of Wound | NA cm |
| AmeriGel® Wound Care Dressing Alone | Wound Area Measurements | Week 10 Width of Wound | NA cm |
| AmeriGel® Wound Care Dressing Alone | Wound Area Measurements | Week 10 Depth of Wound | NA cm |
| AmeriGel® Wound Care Dressing Alone | Wound Area Measurements | Week 10 Length of Wound | NA cm |
| AmeriGel® Wound Care Dressing Alone | Wound Area Measurements | Week 12 Width of Wound | NA cm |
| AmeriGel® Wound Care Dressing Alone | Wound Area Measurements | Week 12 Depth of Wound | NA cm |
| AmeriGel® Wound Care Dressing Alone | Wound Area Measurements | Week 12 Length of Wound | NA cm |
| AmeriGel® Wound Care Dressing Alone | Wound Area Measurements | Week 14 Width of Wound | NA cm |
| AmeriGel® Wound Care Dressing Alone | Wound Area Measurements | Week 14 Depth of Wound | NA cm |
| AmeriGel® Wound Care Dressing Alone | Wound Area Measurements | Week 14 Length of Wound | NA cm |
| AmeriGel® Wound Care Dressing Alone | Wound Area Measurements | Week 16 Width of Wound | NA cm |
| AmeriGel® Wound Care Dressing Alone | Wound Area Measurements | Week 16 Depth of Wound | NA cm |
| AmeriGel® Wound Care Dressing Alone | Wound Area Measurements | Week 16 Length of Wound | NA cm |
| AmeriGel® Wound Care Dressing Alone | Wound Area Measurements | Week 18 Width of Wound | NA cm |
| AmeriGel® Wound Care Dressing Alone | Wound Area Measurements | Week 18 Depth of Wound | NA cm |
| AmeriGel® Wound Care Dressing Alone | Wound Area Measurements | Week 18 Length of Wound | NA cm |
| AmeriGel® Wound Care Dressing Alone | Wound Area Measurements | Week 20 Width of Wound | NA cm |
| AmeriGel® Wound Care Dressing Alone | Wound Area Measurements | Week 8 Depth of Wound | NA cm |