The Relationship of Hemoglobin A1c and Diabetic Wound Healing

Foot Ulcer, Diabetic Clinical Trial

Official title:

The Relationship of Hemoglobin A1c and Diabetic Wound Healing

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01350102
• Other study ID #: IRB-35832
• Status: Terminated
• Phase: Phase 4
• First received: May 4, 2011
• Last updated: November 13, 2017
• Start date: February 2012
• Est. completion date: March 2014

Study information

• Verified date: November 2017
• Source: Milton S. Hershey Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 closure.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Diabetes Mellitus, Type 2
• Diabetes, Type 1
• Diabetes, Type 2
• Diabetic Foot
• Foot Ulcer
• Foot Ulcer, Diabetic

Intervention

Drug:
• Bacitracin
Participants will be treated with Bacitracin to their wound until 100% wound healing, which may take up to 6 months to achieve.
• AmeriGel®
Participants will be treated with AmeriGel® to their wound until 100% wound healing, which may take up to 6 months to achieve.

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

Locations

Country	Name	City	State
United States	Penn State Milton S. Hershey Medical Center	Hershey	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Susan Hassenbein

Country where clinical trial is conducted

United States, 

References & Publications (21)

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

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

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

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. — View Citation

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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. — View Citation

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. — View Citation

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. — View Citation

Maklebust JA, Margolis D. The goodness of measurement. Adv Wound Care. 1996 May-Jun;9(3):6. — View Citation

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. — View Citation

Pollack SV. Wound healing: a review. III. Nutritional factors affecting wound healing. J Dermatol Surg Oncol. 1979 Aug;5(8):615-9. — View Citation

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. — View Citation

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

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. — View Citation

Storm DR. Mechanism of bacitracin action: a specific lipid-peptide interaction. Ann N Y Acad Sci. 1974 May 10;235(0):387-98. — View Citation

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. doi: 10.1016/j.nut.2010.05.009. Epub 2010 Jul 3. — View Citation

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.

Vitamin C and the common cold. Med Lett Drugs Ther. 1970 Dec 25;12(26):105-6. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 21 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Patients are assessed every 3 months from enrollment through end of study participation, which may be 6 months
Secondary	Length of Time for Wound Closure	Length of time for wound closure will be measured in days	Patients are assessed every other week (bi-weekly) until 100% wound healing is achieved, which may take up to 6 months
Secondary	Wound Area Measurements	Wound area measurements in length, width, and depth throughout the course of the study(measured in cm).	Patients are assessed every other week (bi-weekly) until 100% wound healing is achieved, which may take up to 6 months