The Relationship of Hemoglobin A1c and Diabetic Wound Healing

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ClinicalTrials.gov Identifier: NCT01350102

Recruitment Status : Terminated (study closed due to recruitment problems)

First Posted : May 9, 2011

Results First Posted : December 12, 2017

Last Update Posted : December 12, 2017

View this study on Beta.ClinicalTrials.gov

Sponsor:

Information provided by (Responsible Party):

Susan Hassenbein, Milton S. Hershey Medical Center

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Diabetes, Type 1 Diabetes, Type 2 Foot Ulcer, Diabetic	Drug: Bacitracin Drug: AmeriGel® Dietary Supplement: Vitamin C	Phase 4

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

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	2 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	The Relationship of Hemoglobin A1c and Diabetic Wound Healing
Study Start Date :	February 2012
Actual Primary Completion Date :	March 2014
Actual Study Completion Date :	March 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: A1C Vitamin C Wounds and Injuries

Drug Information available for: Ascorbic acid Sodium ascorbate Bacitracin Bacitracin zinc Magnesium ascorbate

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Bacitracin wound care dressing alone Bacitracin wound care dressing alone	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 Name: Baciguent
Active Comparator: Bacitracin with Vit C Bacitracin wound care dressing with Vitamin C supplementation	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 Name: Baciguent 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 Name: ascorbic acid
Active Comparator: AmeriGel® wound care dressing alone AmeriGel® wound care dressing alone	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
Active Comparator: AmeriGel® with Vit C AmeriGel® wound care dressing with Vitamin C supplementation	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 Name: ascorbic acid

Outcome Measures

Primary Outcome Measures :

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.

Secondary Outcome Measures :

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 ]
Length of time for wound closure will be measured in days
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 ]
Wound area measurements in length, width, and depth throughout the course of the study(measured in cm).

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01350102

Locations

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United States, Pennsylvania
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033

Sponsors and Collaborators

Susan Hassenbein

Investigators

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Principal Investigator:	Nell V. Blake, DPM	Milton S. Hershey Medical Center

More Information

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.

Jensen 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.

Storm 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.

Falabella A, Falanga V. Uncommon causes of ulcers. Clin Plast Surg. 1998 Jul;25(3):467-79.

Lazarus 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.

Maklebust JA, Margolis D. The goodness of measurement. Adv Wound Care. 1996 May-Jun;9(3):6. No abstract available.

van 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.

Haslik 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.

Droog 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.

Duckworth 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.

Zimny 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.

Rubinstein 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.

Yue 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.

Vitamin C and the common cold. Med Lett Drugs Ther. 1970 Dec 25;12(26):105-6. No abstract available.

Howe GR, Hirohata T, Hislop TG, Iscovich JM, Yuan JM, Katsouyanni K, Lubin F, Marubini E, Modan B, Rohan T, et al. Dietary factors and risk of breast cancer: combined analysis of 12 case-control studies. J Natl Cancer Inst. 1990 Apr 4;82(7):561-9. doi: 10.1093/jnci/82.7.561.

Wassertheil-Smoller S, Romney SL, Wylie-Rosett J, Slagle S, Miller G, Lucido D, Duttagupta C, Palan PR. Dietary vitamin C and uterine cervical dysplasia. Am J Epidemiol. 1981 Nov;114(5):714-24. doi: 10.1093/oxfordjournals.aje.a113243.

Snyder RJ, Kirsner RS, Warriner RA 3rd, Lavery LA, Hanft JR, Sheehan P. Consensus recommendations on advancing the standard of care for treating neuropathic foot ulcers in patients with diabetes. Ostomy Wound Manage. 2010 Apr;56(4 Suppl):S1-24.

Pollack SV. Wound healing: a review. III. Nutritional factors affecting wound healing. J Dermatol Surg Oncol. 1979 Aug;5(8):615-9. doi: 10.1111/j.1524-4725.1979.tb00733.x.

van Anholt RD, Sobotka L, Meijer EP, Heyman H, Groen HW, Topinkova E, van Leen M, Schols JM. Specific nutritional support accelerates pressure ulcer healing and reduces wound care intensity in non-malnourished patients. Nutrition. 2010 Sep;26(9):867-72. doi: 10.1016/j.nut.2010.05.009. Epub 2010 Jul 3.

Smith RG. Validation of Wagner's classification: a literature review. Ostomy Wound Manage. 2003 Jan;49(1):54-62.

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Responsible Party:	Susan Hassenbein, Clinical Research Associate, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier:	NCT01350102
Other Study ID Numbers:	IRB-35832
First Posted:	May 9, 2011 Key Record Dates
Results First Posted:	December 12, 2017
Last Update Posted:	December 12, 2017
Last Verified:	November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

Keywords provided by Susan Hassenbein, Milton S. Hershey Medical Center:


Adult

Additional relevant MeSH terms:

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Diabetic Foot Foot Ulcer Diabetes Mellitus Diabetes Mellitus, Type 2 Diabetes Mellitus, Type 1 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Foot Diseases Skin Diseases Leg Ulcer Skin Ulcer Diabetic Angiopathies Vascular Diseases Cardiovascular Diseases	Diabetes Complications Diabetic Neuropathies Autoimmune Diseases Immune System Diseases Ascorbic Acid Bacitracin Vitamins Micronutrients Physiological Effects of Drugs Antioxidants Molecular Mechanisms of Pharmacological Action Protective Agents Anti-Infective Agents, Local Anti-Infective Agents Anti-Bacterial Agents

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