Trial Outcomes & Findings for The Relationship of Hemoglobin A1c and Diabetic Wound Healing (NCT NCT01350102)

Last Updated: 2017-12-12

Results Overview

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.

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

2 participants

Primary outcome timeframe

Patients are assessed every 3 months from enrollment through end of study participation, which may be 6 months

Results posted on

2017-12-12

Participant Flow

Two subjects were screened and enrolled at the clinic site on 2/24/2012 and 1/14/2013.

Participant milestones

Participant milestones
Measure	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	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
Overall Study STARTED	1	1
Overall Study COMPLETED	1	0
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	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	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	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	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
Overall Study Adverse Event	0	0	1	0

Baseline Characteristics

The Relationship of Hemoglobin A1c and Diabetic Wound Healing

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	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	Bacitracin With Vit C n=1 Participants 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 n=1 Participants 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® 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	Total n=2 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	2 Participants n=21 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	2 Participants n=21 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Region of Enrollment United States	—	1 Participants n=7 Participants	1 Participants n=5 Participants	—	2 Participants n=21 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	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	Bacitracin With Vit C n=1 Participants 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 n=1 Participants 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® 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
Hgb A1c Level Enrollment A1c	—	5.2 percentage of hemoglobin	12.1 percentage of hemoglobin	—
Hgb A1c Level 3 Month A1c	—	6.1 percentage of hemoglobin	NA percentage of hemoglobin A1c not taken - patient withdrawn from study prior to 3 months	—

SECONDARY outcome

Timeframe: 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.

Length of time for wound closure will be measured in days

Outcome measures

Outcome measures
Measure	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	Bacitracin With Vit C n=1 Participants 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® 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® 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
Length of Time for Wound Closure	—	141 Days	—	—

SECONDARY outcome

Timeframe: 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.

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

Outcome measures

Outcome measures
Measure	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	Bacitracin With Vit C n=1 Participants 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 n=1 Participants 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® 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
Wound Area Measurements Week 8 Length of Wound	—	0.1 cm	NA cm Withdrawn from study	—
Wound Area Measurements Week 18 Width of Wound	—	0.3 cm	NA cm Withdrawn from study	—
Wound Area Measurements Week 18 Depth of Wound	—	0.1 cm	NA cm Withdrawn from study	—
Wound Area Measurements Week 18 Length of Wound	—	0.3 cm	NA cm Withdrawn from study	—
Wound Area Measurements Week 0 Width of Wound	—	0.9 cm	0.3 cm	—
Wound Area Measurements Week 0 Depth of Wound	—	0.2 cm	0.2 cm	—
Wound Area Measurements Week 0 Length of Wound	—	1.0 cm	2 cm	—
Wound Area Measurements Week 2 Width of Wound	—	0.4 cm	0.5 cm	—
Wound Area Measurements Week 2 Depth of Wound	—	0.1 cm	0.2 cm	—
Wound Area Measurements Week 2 Length of Wound	—	0.5 cm	0.5 cm	—
Wound Area Measurements Week 4 Width of Wound	—	0.4 cm	NA cm Withdrawn from study	—
Wound Area Measurements Week 4 Depth of Wound	—	0.1 cm	NA cm Withdrawn from study	—
Wound Area Measurements Week 4 Length of Wound	—	0.5 cm	NA cm Withdrawn from study	—
Wound Area Measurements Week 6 Width of Wound	—	0.2 cm	NA cm Withdrawn from study	—
Wound Area Measurements Week 6 Depth of Wound	—	0.1 cm	NA cm Withdrawn from study	—
Wound Area Measurements Week 6 Length of Wound	—	0.2 cm	NA cm Withdrawn from study	—
Wound Area Measurements Week 8 Width of Wound	—	0.1 cm	NA cm Withdrawn from study	—
Wound Area Measurements Week 8 Depth of Wound	—	0.3 cm	NA cm Withdrawn from study	—
Wound Area Measurements Week 10 Width of Wound	—	0.1 cm	NA cm Withdrawn from study	—
Wound Area Measurements Week 10 Depth of Wound	—	0.1 cm	NA cm Withdrawn from study	—
Wound Area Measurements Week 10 Length of Wound	—	0.2 cm	NA cm Withdrawn from study	—
Wound Area Measurements Week 12 Width of Wound	—	0.1 cm	NA cm Withdrawn from study	—
Wound Area Measurements Week 12 Depth of Wound	—	0.1 cm	NA cm Withdrawn from study	—
Wound Area Measurements Week 12 Length of Wound	—	0.3 cm	NA cm Withdrawn from study	—
Wound Area Measurements Week 14 Width of Wound	—	0.1 cm	NA cm Withdrawn from study	—
Wound Area Measurements Week 14 Depth of Wound	—	0.1 cm	NA cm Withdrawn from study	—
Wound Area Measurements Week 14 Length of Wound	—	0.3 cm	NA cm Withdrawn from study	—
Wound Area Measurements Week 16 Width of Wound	—	0.1 cm	NA cm Withdrawn from study	—
Wound Area Measurements Week 16 Depth of Wound	—	0.1 cm	NA cm Withdrawn from study	—
Wound Area Measurements Week 16 Length of Wound	—	0.1 cm	NA cm Withdrawn from study	—
Wound Area Measurements Week 20 Width of Wound	—	0.0 cm	NA cm Withdrawn from study	—
Wound Area Measurements Week 20 Depth of Wound	—	0.0 cm	NA cm Withdrawn from study	—
Wound Area Measurements Week 20 Length of Wound	—	0.0 cm	NA cm Withdrawn from study	—

Adverse Events

Bacitracin Wound Care Dressing Alone

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Bacitracin With Vit C

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

AmeriGel® Wound Care Dressing Alone

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

AmeriGel® With Vit C

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	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	Bacitracin With Vit C n=1 participants at risk 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 n=1 participants at risk 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® 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
Infections and infestations Infection	— 0/0 • enrollment through 20 weeks	0.00% 0/1 • enrollment through 20 weeks	100.0% 1/1 • Number of events 1 • enrollment through 20 weeks	— 0/0 • enrollment through 20 weeks

Additional Information

Nell Blake, DPM

Penn State Milton S. Hershey Medical Center

Phone: (717) 531-5638

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place