The Relationship of Hemoglobin A1c and Diabetic Wound Healing
NCT ID: NCT01350102
Last Updated: 2017-12-12
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
PHASE4
2 participants
INTERVENTIONAL
2012-02-29
2014-03-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
The Role of TBC1D4 in Exercise- and Insulin-induced Glucose Metabolism in Human Skeletal Muscle
NCT04170972
The Metabolic Effects of Acute Hyperglycemia in Patients With Type 2 Diabetes
NCT00653510
Time To Complications Occurs in Diabetes
NCT00969956
Can Tailored Patient Letters Improve The Quality Of Diabetic Patient Care?
NCT00984841
Study of Cellular Impairments Involved in Diabetic Complications
NCT00985101
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Bacitracin wound care dressing alone
Bacitracin wound care dressing alone
Bacitracin
Participants will be treated with Bacitracin to their wound until 100% wound healing, which may take up to 6 months to achieve.
Bacitracin with Vit C
Bacitracin wound care dressing with Vitamin C supplementation
Bacitracin
Participants will be treated with Bacitracin to their wound until 100% wound healing, which may take up to 6 months to achieve.
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
AmeriGel® wound care dressing alone
AmeriGel® wound care dressing alone
AmeriGel®
Participants will be treated with AmeriGel® to their wound until 100% wound healing, which may take up to 6 months to achieve.
AmeriGel® with Vit C
AmeriGel® wound care dressing with Vitamin C supplementation
AmeriGel®
Participants will be treated with AmeriGel® to their wound until 100% wound healing, which may take up to 6 months to achieve.
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
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
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 Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Susan Hassenbein
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Susan Hassenbein
Clinical Research Associate
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Nell V. Blake, DPM
Role: PRINCIPAL_INVESTIGATOR
Milton S. Hershey Medical Center
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
IRB-35832
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.