The Relationship of Hemoglobin A1c and Diabetic Wound Healing - Full Text View

Purpose

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	Intervention	Phase
Diabetes, Type 1 Diabetes, Type 2 Foot Ulcer, Diabetic	Drug: Bacitracin Drug: AmeriGel® Procedure: Hemoglobin A1c Dietary Supplement: Vitamin C	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	The Relationship of Hemoglobin A1c and Diabetic Wound Healing

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Foot Health Vitamin C

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

U.S. FDA Resources

Further study details as provided by Milton S. Hershey Medical Center:

Primary Outcome Measures:

Wound healing [ Time Frame: Patients are assessed every other week (bi-weekly) until 100% wound healing is achieved, which may take up to 6 months ] [ Designated as safety issue: No ]
Assessment of wound healing will be assessed on a biweekly basis. Healing will be defined as 100% wound re-epithelialization or wound closure. Wounds will be measured in regard to width and depth, digital images taken, and the wound assessed according to standard wound descriptors at each visit until 100% wound healing. The wound will also be given a Wagner classification. Patients will record dressing application, non-weight bearing status, and vitamin C consumption. Hgb A1c and vitamin C levels will be drawn at enrollment and at three month intervals. Wound healing may take up to 6 months.

Estimated Enrollment:	40
Study Start Date:	February 2012
Estimated Study Completion Date:	December 2014
Estimated Primary Completion Date:	December 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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 Procedure: Hemoglobin A1c Hemoglobin A1c levels will be performed and reviewed every three months to assess its relationship to wound healing
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 Procedure: Hemoglobin A1c Hemoglobin A1c levels will be performed and reviewed every three months to assess its relationship to wound healing 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 Procedure: Hemoglobin A1c Hemoglobin A1c levels will be performed and reviewed every three months to assess its relationship to wound healing
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 Procedure: Hemoglobin A1c Hemoglobin A1c levels will be performed and reviewed every three months to assess its relationship to wound healing 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

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT01350102

Locations

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

Sponsors and Collaborators

Susan Hassenbein

Investigators

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.

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. No abstract available.

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

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. Review.

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

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. Review.

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.

Droog EJ, Steenbergen W, Sjöberg F. Measurement of depth of burns by laser Doppler perfusion imaging. Burns. 2001 Sep;27(6):561-8.

Duckworth WC, Fawcett J, Reddy S, Page JC. Insulin-degrading activity in wound fluid. J Clin Endocrinol Metab. 2004 Feb;89(2):847-51.

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.

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.

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.

[No authors listed] 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.

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.

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.

van Anholt RD, Sobotka L, Meijer EP, Heyman H, Groen HW, Topinková 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. Epub 2010 Jul 3.

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

Responsible Party:	Susan Hassenbein, Clinical Research Associate, Penn State Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier:	NCT01350102 History of Changes
Other Study ID Numbers:	IRB-35832
Study First Received:	May 4, 2011
Last Updated:	January 8, 2013
Health Authority:	United States: Food and Drug Administration

Keywords provided by Milton S. Hershey Medical Center:

Adult

Additional relevant MeSH terms:

Diabetes Mellitus
Diabetes Mellitus, Type 2
Foot Ulcer
Diabetic Foot
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
Ascorbic Acid
Vitamins
Bacitracin
Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs
Micronutrients
Growth Substances
Anti-Infective Agents, Local
Anti-Infective Agents
Therapeutic Uses
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on May 23, 2013