- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01350102
The Relationship of Hemoglobin A1c and Diabetic Wound Healing
November 13, 2017 updated by: Susan Hassenbein
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
2
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Pennsylvania
-
Hershey, Pennsylvania, United States, 17033
- Penn State Milton S. Hershey Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Bacitracin wound care dressing alone
|
Participants will be treated with Bacitracin to their wound until 100% wound healing, which may take up to 6 months to achieve.
Other Names:
|
Active Comparator: Bacitracin with Vit C
Bacitracin wound care dressing with Vitamin C supplementation
|
Participants will be treated with Bacitracin to their wound until 100% wound healing, which may take up to 6 months to achieve.
Other Names:
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 Names:
|
Active Comparator: AmeriGel® wound care dressing alone
|
Participants will be treated with AmeriGel® to their wound until 100% wound healing, which may take up to 6 months to achieve.
Other Names:
|
Active Comparator: AmeriGel® with Vit C
AmeriGel® wound care dressing with Vitamin C supplementation
|
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 Names:
Participants will be treated with AmeriGel® to their wound until 100% wound healing, which may take up to 6 months to achieve.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Patients are assessed every 3 months from enrollment through end of study participation, which may be 6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Patients are assessed every other week (bi-weekly) until 100% wound healing is achieved, which may take up to 6 months
|
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).
|
Patients are assessed every other week (bi-weekly) until 100% wound healing is achieved, which may take up to 6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Nell V. Blake, DPM, Milton S. Hershey Medical Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2012
Primary Completion (Actual)
March 1, 2014
Study Completion (Actual)
March 1, 2014
Study Registration Dates
First Submitted
May 4, 2011
First Submitted That Met QC Criteria
May 6, 2011
First Posted (Estimate)
May 9, 2011
Study Record Updates
Last Update Posted (Actual)
December 12, 2017
Last Update Submitted That Met QC Criteria
November 13, 2017
Last Verified
November 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Glucose Metabolism Disorders
- Metabolic Diseases
- Skin Diseases
- Immune System Diseases
- Autoimmune Diseases
- Endocrine System Diseases
- Diabetic Angiopathies
- Leg Ulcer
- Skin Ulcer
- Diabetes Complications
- Diabetic Neuropathies
- Foot Diseases
- Diabetes Mellitus
- Diabetes Mellitus, Type 2
- Diabetic Foot
- Foot Ulcer
- Diabetes Mellitus, Type 1
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents, Local
- Anti-Infective Agents
- Protective Agents
- Micronutrients
- Anti-Bacterial Agents
- Vitamins
- Antioxidants
- Ascorbic Acid
- Bacitracin
Other Study ID Numbers
- IRB-35832
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Foot Ulcer, Diabetic
-
University of MinnesotaRecruitingDiabetes Mellitus | Foot Ulcer | Ulcer | Diabetic Foot Ulcer | Foot Ulcer, Diabetic | Ulcer Foot | Ulcer, Leg | Ankle UlcerUnited States
-
Community Pharmacology Services LtdKeneric HealthcareNot yet recruitingDiabetic Foot Ulcer | Diabetic Foot Ulcer Neuropathic | Diabetic Foot Ulcer Ischemic
-
University of PadovaUnknownDiabetic Foot | Diabetic Foot Ulcer | Diabetic Foot Infection | Diabetic Foot Ulcer Neuropathic | Deformities FootItaly
-
Johns Hopkins UniversityWithdrawnDiabetic Foot | Diabetic Foot Ulcer | Diabetic Foot Infection | Diabetic Foot Ulcer Mixed | Vascular Ulcer (Arterial or Venous Including Diabetic Ulcers Not Located on the Foot)
-
Corporacion Parc TauliCompletedDiabetic Foot Ulcer | Diabetic Foot Ulcer NeuropathicPakistan
-
Baylor College of MedicineLifeNet HealthCompletedDiabetic Foot Ulcer | Deep Diabetic Foot UlcerUnited States
-
Exciton Technologies Inc.CompletedDiabetic Foot Ulcer | Diabetic Foot Infection | Non-healing Diabetic Foot UlcerCanada
-
National and Kapodistrian University of AthensTerminatedDiabetic Foot | Chronic Diabetic Foot Ulcer of Right Foot | Neuropathic Foot Ulcer | Chronic Diabetic Ulcer of Left Foot (Diagnosis)Greece
-
ETS Wound Care, LLCProfessional Education and Research InstituteCompletedDiabetic Foot | Diabetic Foot Ulcer | Ulcer FootUnited States
-
University of the PunjabHigher Education Commission (Pakistan); Centre of Excellence in Molecular Biology... and other collaboratorsRecruitingDiabetes Mellitus | Diabetic Foot | Foot Ulcer | Diabetes Complications | Diabetic Foot Ulcer | Diabetic Foot Infection | Diabetic Foot Ulcer Neuropathic | Foot Ulcer Due to Type 1 Diabetes Mellitus | Foot Ulcer Due to Type 2 Diabetes Mellitus | Chronic Diabetic Ulcer of Left Foot | Chronic Diabetic Foot...Pakistan
Clinical Trials on Bacitracin
-
Mekos Laboratories ASCompleted
-
HealthpointCompletedNon-melanoma Skin CancerUnited States
-
MetroHealth Medical CenterWithdrawn
-
University of Kansas Medical CenterUnknownBurn, Partial ThicknessUnited States
-
Population Health Research InstituteCompleted
-
California Institute of Renal ResearchImprimis Pharmaceuticals, Inc.CompletedArteriovenous FistulaUnited States
-
Northwestern UniversityCompletedNasal Carriers of Staphylococcus AureusUnited States
-
University of TennesseeMedline IndustriesCompletedBurns | Partial-thickness BurnUnited States
-
University of California, San FranciscoCompletedSurgical Wound Infection | Surgical Site Infection | Eyelid Diseases | Skin Cancer Face | Surgical Incision | Antibiotic Side Effect | Antibiotic Allergy | Surgical Wound, Recent | Eyelid; WoundUnited States
-
National Institute of Allergy and Infectious Diseases...Glaxo WellcomeCompletedHIV Infections | Herpes SimplexUnited States