The Relationship of Hemoglobin A1c and Diabetic Wound Healing

NCT01350102 | Terminated Phase 4 Results

• 1 other identifier: IRB-35832
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes, Type 1; Diabetes, Type 2; Foot Ulcer, Diabetic

Keywords

Adult

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Length of Time for Wound Closure

  Patients are assessed every other week (bi-weekly) until 100% wound healing is achieved, which may take up to 6 months

• Wound Area Measurements

  Patients are assessed every other week (bi-weekly) until 100% wound healing is achieved, which may take up to 6 months

Study Arms (4)

Bacitracin wound care dressing alone

ACTIVE COMPARATOR

Bacitracin wound care dressing alone

Drug: Bacitracin

Bacitracin with Vit C

ACTIVE COMPARATOR

Bacitracin wound care dressing with Vitamin C supplementation

Drug: Bacitracin; Dietary Supplement: Vitamin C

AmeriGel® wound care dressing alone

ACTIVE COMPARATOR

AmeriGel® wound care dressing alone

Drug: AmeriGel®

AmeriGel® with Vit C

ACTIVE COMPARATOR

AmeriGel® wound care dressing with Vitamin C supplementation

Drug: AmeriGel®; Dietary Supplement: Vitamin C

Interventions

Bacitracin DRUG

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

Also known as: Baciguent

Bacitracin with Vit C; Bacitracin wound care dressing alone

AmeriGel® DRUG

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

Also known as: Oakin®-based hydrogel, hydrogel containing Oakin®, Oak extract

AmeriGel® with Vit C; AmeriGel® wound care dressing alone

Vitamin C DIETARY_SUPPLEMENT

Participants will be treated with Vitamin C supplements 1000 mg daily until 100% wound healing, which may take up to 6 months to achieve

Also known as: ascorbic acid

AmeriGel® with Vit C; Bacitracin with Vit C

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \>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

You may not qualify if:

• 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

Sponsors & Collaborators

• Susan Hassenbein: lead

Study Sites (1)

Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

Related Publications (21)

• 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.

  PMID: 19638800 BACKGROUND

• 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.

  PMID: 10326334 BACKGROUND

• 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.

  PMID: 4368896 BACKGROUND

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

  PMID: 9696906 BACKGROUND

• 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.

  PMID: 8166487 BACKGROUND

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

  PMID: 8716267 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 15230830 BACKGROUND

• 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.

  PMID: 15082349 BACKGROUND

• 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.

  PMID: 11525849 BACKGROUND

• 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.

  PMID: 14764804 BACKGROUND

• 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.

  PMID: 12200075 BACKGROUND

• 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.

  PMID: 3043987 BACKGROUND

• 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.

  PMID: 3803737 BACKGROUND

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

  PMID: 4936077 BACKGROUND

• 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.

  PMID: 2156081 BACKGROUND

• 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.

  PMID: 7304600 BACKGROUND

• 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.

  PMID: 20424290 BACKGROUND

• 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.

  PMID: 479447 BACKGROUND

• 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.

  PMID: 20598855 BACKGROUND

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

  PMID: 12532034 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2; Diabetic Foot

Interventions

Bacitracin; oak bark extract; Ascorbic Acid

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetic Neuropathies

Intervention Hierarchy (Ancestors)

Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins; Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates

Limitations and Caveats

Study terminated due to recruitment issues - only two subjects enrolled in study.

Results Point of Contact

• Title: Nell Blake, DPM
• Organization: Penn State Milton S. Hershey Medical Center

nblake@pennstatehealth.psu.edu

(717) 531-5638

Study Officials

• Nell V. Blake, DPM

  Milton S. Hershey Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Research Associate

Study Record Dates

• First Submitted: May 4, 2011
• First Posted: May 9, 2011
• Study Start: February 1, 2012
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: December 12, 2017
• Results First Posted: December 12, 2017

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)