Diabetes, Type 1Phase 4NCT01350102
The Relationship of Hemoglobin A1c and Diabetic Wound Healing
A Phase 4 study testing Bacitracin, AmeriGel® and Vitamin C in people with Diabetes, Type 1 and Diabetes, Type 2, run by Susan Hassenbein at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes, Type 1, Diabetes, Type 2, Foot Ulcer, Diabetic
- What is being tested?
- Bacitracin, AmeriGel® and Vitamin C
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2012to Mar 2014
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- >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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033
About this study
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.
Read the 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.
- Conditions
- Diabetes, Type 1, Diabetes, Type 2, Foot Ulcer, Diabetic
- Being tested
- Bacitracin, AmeriGel®, Vitamin C
- Keywords
- Adult
- Medical subject headings
- Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2, Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BacitracinDrug
Also called Baciguent
Participants will be treated with Bacitracin to their wound until 100% wound healing, which may take up to 6 months to achieve.
AmeriGel®Drug
Also called Oakin®-based hydrogel, hydrogel containing Oakin®, Oak extract
Participants will be treated with AmeriGel® to their wound until 100% wound healing, which may take up to 6 months to achieve.
Vitamin CDietary supplement
Also called ascorbic acid
Participants will be treated with Vitamin C supplements 1000 mg daily until 100% wound healing, which may take up to 6 months to achieve
| Study group | Role | What they receive |
|---|---|---|
| Bacitracin wound care dressing alone | Active comparator | Bacitracin wound care dressing alone Receives: Drug: Bacitracin |
| Bacitracin with Vit C | Active comparator | Bacitracin wound care dressing with Vitamin C supplementation Receives: Drug: Bacitracin; Dietary Supplement: Vitamin C |
| AmeriGel® wound care dressing alone | Active comparator | AmeriGel® wound care dressing alone Receives: Drug: AmeriGel® |
| AmeriGel® with Vit C | Active comparator | AmeriGel® wound care dressing with Vitamin C supplementation Receives: Drug: AmeriGel®; Dietary Supplement: Vitamin C |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Patients are assessed every 3 months from enrollment through end of study participation, which may be 6 months
Secondary outcomes (2)
Length of Time for Wound Closure
Length of time for wound closure will be measured in days
Measured: 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).
Measured: Patients are assessed every other week (bi-weekly) until 100% wound healing is achieved, which may take up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2011 (estimated)
- Study startFeb 2012
- Primary completionMar 2014
- Study completionMar 2014
Why it stopped: study closed due to recruitment problems
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for Diabetes, Type 1Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Susan Hassenbein
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Susan Hassenbein, Milton S. Hershey Medical Center
- Investigators
- Nell V. Blake, DPM, Principal investigator, Milton S. Hershey Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01350102
- Sponsor's protocol ID
- IRB-35832
- Status last verified
- Nov 2017
- First submitted
- 4 May 2011
- Last updated
- 12 Dec 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Markuson M, Hanson D, Anderson J, Langemo D, Hunter S, Thompson P, Paulson R, Rustvang D. The relationship between hemoglobin A(1c) values and healing time for lower extremity ulcers in individuals with diabetes. Adv Skin Wound Care. 2009 Aug;22(8):365-72. doi: 10.1097/01.ASW.0000358639.45784.cd.
PubMed 19638800Jensen JL, Seeley J, Gillin B. Diabetic foot ulcerations. A controlled, randomized comparison of two moist wound healing protocols: Carrasyn Hydrogel Wound dressing and wet-to-moist saline gauze. Adv Wound Care. 1998 Nov-Dec;11(7 Suppl):1-4. No abstract available.
PubMed 10326334Storm DR. Mechanism of bacitracin action: a specific lipid-peptide interaction. Ann N Y Acad Sci. 1974 May 10;235(0):387-98. doi: 10.1111/j.1749-6632.1974.tb43278.x. No abstract available.
PubMed 4368896Falabella A, Falanga V. Uncommon causes of ulcers. Clin Plast Surg. 1998 Jul;25(3):467-79.
PubMed 9696906Lazarus GS, Cooper DM, Knighton DR, Margolis DJ, Pecoraro RE, Rodeheaver G, Robson MC. Definitions and guidelines for assessment of wounds and evaluation of healing. Arch Dermatol. 1994 Apr;130(4):489-93.
PubMed 8166487Maklebust JA, Margolis D. The goodness of measurement. Adv Wound Care. 1996 May-Jun;9(3):6. No abstract available.
PubMed 8716267van Rijuswijl L. Wound assessment and documentation. In: Krasner LD, Rodeheaver GT, Sibbald RG (eds). Chronic Wound Care: A Clinical Source Book for Healthcare Professionals, 3rd ed. Wayne Pa: HMP Communications: 2001;101-115.
Keast DH, Bowering CK, Evans AW, Mackean GL, Burrows C, D'Souza L. MEASURE: A proposed assessment framework for developing best practice recommendations for wound assessment. Wound Repair Regen. 2004 May-Jun;12(3 Suppl):S1-17. doi: 10.1111/j.1067-1927.2004.0123S1.x.
PubMed 15230830Haslik W, Kamolz LP, Andel H, Winter W, Meissl G, Frey M. The influence of dressings and ointments on the qualitative and quantitative evaluation of burn wounds by ICG video-angiography: an experimental setup. Burns. 2004 May;30(3):232-5. doi: 10.1016/j.burns.2003.10.016.
PubMed 15082349Droog EJ, Steenbergen W, Sjoberg F. Measurement of depth of burns by laser Doppler perfusion imaging. Burns. 2001 Sep;27(6):561-8. doi: 10.1016/s0305-4179(01)00021-3.
PubMed 11525849Duckworth WC, Fawcett J, Reddy S, Page JC. Insulin-degrading activity in wound fluid. J Clin Endocrinol Metab. 2004 Feb;89(2):847-51. doi: 10.1210/jc.2003-031371.
PubMed 14764804Zimny S, Schatz H, Pfohl M. Determinants and estimation of healing times in diabetic foot ulcers. J Diabetes Complications. 2002 Sep-Oct;16(5):327-32. doi: 10.1016/s1056-8727(01)00217-3.
PubMed 12200075Rubinstein A, Pierce CE Jr. Rapid healing of diabetic foot ulcers with meticulous blood glucose control. Acta Diabetol Lat. 1988 Jan-Mar;25(1):25-32. doi: 10.1007/BF02581242.
PubMed 3043987Yue DK, McLennan S, Marsh M, Mai YW, Spaliviero J, Delbridge L, Reeve T, Turtle JR. Effects of experimental diabetes, uremia, and malnutrition on wound healing. Diabetes. 1987 Mar;36(3):295-9. doi: 10.2337/diab.36.3.295.
PubMed 3803737Vitamin C and the common cold. Med Lett Drugs Ther. 1970 Dec 25;12(26):105-6. No abstract available.
PubMed 4936077
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship of Hemoglobin A1c and Diabetic Wound Healing
- ClinicalTrials.gov ID
- NCT01350102
- Acronym / sponsor ID
- IRB-35832
- Conditions
- Diabetes, Type 1, Diabetes, Type 2, Foot Ulcer, Diabetic
- Keywords
- Adult
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: study closed due to recruitment problems
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Susan HassenbeinUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 9 May 2011 (estimated)
- Results
- Posted 12 Dec 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Bacitracin wound care dressing alone | Active comparator | Drug: BacitracinBacitracin wound care dressing alone |
| Bacitracin with Vit C | Active comparator | Drug: Bacitracin, Dietary Supplement: Vitamin CBacitracin wound care dressing with Vitamin C supplementation |
| AmeriGel® wound care dressing alone | Active comparator | Drug: AmeriGel®AmeriGel® wound care dressing alone |
| AmeriGel® with Vit C | Active comparator | Drug: AmeriGel®, Dietary Supplement: Vitamin CAmeriGel® wound care dressing with Vitamin C supplementation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- >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
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BacitracinAlso: BaciguentParticipants will be treated with Bacitracin to their wound until 100% wound healing, which may take up to 6 months to achieve. | Drug | Bacitracin with Vit C, Bacitracin wound care dressing alone |
| AmeriGel®Also: Oakin®-based hydrogel, hydrogel containing Oakin®, Oak extractParticipants will be treated with AmeriGel® to their wound until 100% wound healing, which may take up to 6 months to achieve. | Drug | AmeriGel® with Vit C, AmeriGel® wound care dressing alone |
| Vitamin CAlso: ascorbic acidParticipants will be treated with Vitamin C supplements 1000 mg daily until 100% wound healing, which may take up to 6 months to achieve | Dietary supplement | AmeriGel® with Vit C, Bacitracin with Vit C |
Primary outcome
Hgb A1c Level
Time frame: 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.
2 secondary outcomes
Length of Time for Wound Closure
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
Time frame: Patients are assessed every other week (bi-weekly) until 100% wound healing is achieved, which may take up to 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 19638800Markuson M, Hanson D, Anderson J, Langemo D, Hunter S, Thompson P, Paulson R, Rustvang D. The relationship between hemoglobin A(1c) values and healing time for lower extremity ulcers in individuals with diabetes. Adv Skin Wound Care. 2009 Aug;22(8):365-72. doi: 10.1097/01.ASW.0000358639.45784.cd.
- Background: PubMed 10326334Jensen JL, Seeley J, Gillin B. Diabetic foot ulcerations. A controlled, randomized comparison of two moist wound healing protocols: Carrasyn Hydrogel Wound dressing and wet-to-moist saline gauze. Adv Wound Care. 1998 Nov-Dec;11(7 Suppl):1-4. No abstract available.
- Background: PubMed 4368896Storm DR. Mechanism of bacitracin action: a specific lipid-peptide interaction. Ann N Y Acad Sci. 1974 May 10;235(0):387-98. doi: 10.1111/j.1749-6632.1974.tb43278.x. No abstract available.
- Background: PubMed 9696906Falabella A, Falanga V. Uncommon causes of ulcers. Clin Plast Surg. 1998 Jul;25(3):467-79.
- Background: PubMed 8166487Lazarus GS, Cooper DM, Knighton DR, Margolis DJ, Pecoraro RE, Rodeheaver G, Robson MC. Definitions and guidelines for assessment of wounds and evaluation of healing. Arch Dermatol. 1994 Apr;130(4):489-93.
- Background: PubMed 8716267Maklebust JA, Margolis D. The goodness of measurement. Adv Wound Care. 1996 May-Jun;9(3):6. No abstract available.
- Backgroundvan Rijuswijl L. Wound assessment and documentation. In: Krasner LD, Rodeheaver GT, Sibbald RG (eds). Chronic Wound Care: A Clinical Source Book for Healthcare Professionals, 3rd ed. Wayne Pa: HMP Communications: 2001;101-115.
- Background: PubMed 15230830Keast DH, Bowering CK, Evans AW, Mackean GL, Burrows C, D'Souza L. MEASURE: A proposed assessment framework for developing best practice recommendations for wound assessment. Wound Repair Regen. 2004 May-Jun;12(3 Suppl):S1-17. doi: 10.1111/j.1067-1927.2004.0123S1.x.
- Background: PubMed 15082349Haslik W, Kamolz LP, Andel H, Winter W, Meissl G, Frey M. The influence of dressings and ointments on the qualitative and quantitative evaluation of burn wounds by ICG video-angiography: an experimental setup. Burns. 2004 May;30(3):232-5. doi: 10.1016/j.burns.2003.10.016.
- Background: PubMed 11525849Droog EJ, Steenbergen W, Sjoberg F. Measurement of depth of burns by laser Doppler perfusion imaging. Burns. 2001 Sep;27(6):561-8. doi: 10.1016/s0305-4179(01)00021-3.
- Background: PubMed 14764804Duckworth WC, Fawcett J, Reddy S, Page JC. Insulin-degrading activity in wound fluid. J Clin Endocrinol Metab. 2004 Feb;89(2):847-51. doi: 10.1210/jc.2003-031371.
- Background: PubMed 12200075Zimny S, Schatz H, Pfohl M. Determinants and estimation of healing times in diabetic foot ulcers. J Diabetes Complications. 2002 Sep-Oct;16(5):327-32. doi: 10.1016/s1056-8727(01)00217-3.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nell V. Blake, DPM principal investigator
Milton S. Hershey Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Bacitracin, AmeriGel® and Vitamin C in people with Diabetes, Type 1 and Diabetes, Type 2, run by Susan Hassenbein at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 12 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Dec 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hgb A1c Level (time frame: Patients are assessed every 3 months from enrollment through end of study participation, which may be 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01350102, which also lists 21 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2017.