A Phase 4 interventional study of Bacitracin and AmeriGel® in Diabetes, Type 1, Diabetes, Type 2 and Foot Ulcer, Diabetic, sponsored by Susan Hassenbein. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-12-12.
Sponsored by Susan Hassenbein · Phase 4, Interventional, and Treatment
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.
1,054 studies on the registry are indexed under Diabetic Foot; 222 are open to participants now.
This study's enrollment of 2 is below the median of 60 across 826 interventional studies indexed under Diabetic Foot.
Browse Diabetic Foot studies →Susan Hassenbein is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Bacitracin wound care dressing alone
Drug: Bacitracin
Bacitracin wound care dressing with Vitamin C supplementation
Drug: Bacitracin · Dietary Supplement: Vitamin C
AmeriGel® wound care dressing alone
Drug: AmeriGel®
AmeriGel® wound care dressing with Vitamin C supplementation
Drug: AmeriGel® · Dietary Supplement: Vitamin C
Participants will be treated with Bacitracin to their wound until 100% wound healing, which may take up to 6 months to achieve.
Also known as: Baciguent
Participants will be treated with AmeriGel® to their wound until 100% wound healing, which may take up to 6 months to achieve.
Also known as: Oakin®-based hydrogel, hydrogel containing Oakin®, Oak extract
Participants will be treated with Vitamin C supplements 1000 mg daily until 100% wound healing, which may take up to 6 months to achieve
Also known as: ascorbic acid
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
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
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
Two subjects were screened and enrolled at the clinic site on 2/24/2012 and 1/14/2013.
| Milestone | Bacitracin Wound Care Dressing Alone | Bacitracin With Vit C | AmeriGel® Wound Care Dressing Alone | AmeriGel® With Vit C |
|---|---|---|---|---|
| Started | 0 | 1 | 1 | 0 |
| Completed | 0 | 1 | 0 | 0 |
| Not completed | 0 | 0 | 1 | 0 |
| Withdrew: Adverse event | 0 | 0 | 1 | 0 |
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.
| percentage of hemoglobin | Bacitracin Wound Care Dressing Alone | Bacitracin With Vit C | AmeriGel® Wound Care Dressing Alone | AmeriGel® With Vit C |
|---|---|---|---|---|
| Enrollment A1c | — | 5.2 | 12.1 | — |
| 3 Month A1c | — | 6.1 | NA | — |
Length of time for wound closure will be measured in days
| Days | Bacitracin Wound Care Dressing Alone | Bacitracin With Vit C | AmeriGel® Wound Care Dressing Alone | AmeriGel® With Vit C |
|---|---|---|---|---|
| Length of Time for Wound Closure | — | 141 | — | — |
Wound area measurements in length, width, and depth throughout the course of the study(measured in cm).
| cm | Bacitracin Wound Care Dressing Alone | Bacitracin With Vit C | AmeriGel® Wound Care Dressing Alone | AmeriGel® With Vit C |
|---|---|---|---|---|
| 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 | — |
Collected over enrollment through 20 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Bacitracin Wound Care Dressing Alone | — | — | — |
| Bacitracin With Vit C | 0/1 (0%) | 0/1 (0%) | 0/1 (0%) |
| AmeriGel® Wound Care Dressing Alone | 0/1 (0%) | 0/1 (0%) | 1/1 (100%) |
| AmeriGel® With Vit C | — | — | — |
| Event | Bacitracin Wound Care Dressing Alone | Bacitracin With Vit C | AmeriGel® Wound Care Dressing Alone | AmeriGel® With Vit C |
|---|---|---|---|---|
| InfectionInfections and infestations | — | 0/1 | 1/1 | — |
| Age, Categorical(Participants) | Bacitracin Wound Care Dressing Alone | Bacitracin With Vit C | AmeriGel® Wound Care Dressing Alone | AmeriGel® With Vit C | Total |
|---|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 0 | 1 | 1 | 0 | 2 |
| >=65 years | 0 | 0 | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | Bacitracin Wound Care Dressing Alone | Bacitracin With Vit C | AmeriGel® Wound Care Dressing Alone | AmeriGel® With Vit C | Total |
|---|---|---|---|---|---|
| Female | 0 | 1 | 1 | 0 | 2 |
| Male | 0 | 0 | 0 | 0 | 0 |
| Region of Enrollment(Participants) | Bacitracin Wound Care Dressing Alone | Bacitracin With Vit C | AmeriGel® Wound Care Dressing Alone | AmeriGel® With Vit C | Total |
|---|---|---|---|---|---|
| United States | — | 1 | 1 | — | 2 |
Plan to share: No
This study is terminated, as verified in Nov 2017. You cannot join it, but the record below documents what was studied.
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Susan Hassenbein