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The Relationship of Hemoglobin A1c and Diabetic Wound Healing

Primary Purpose

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

Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Bacitracin
AmeriGel®
Vitamin C
Sponsored by
Susan Hassenbein
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes, Type 1 focused on measuring Adult

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Penn State Milton S. Hershey Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

Bacitracin wound care dressing alone

Bacitracin with Vit C

AmeriGel® wound care dressing alone

AmeriGel® with Vit C

Arm Description

Bacitracin wound care dressing alone

Bacitracin wound care dressing with Vitamin C supplementation

AmeriGel® wound care dressing alone

AmeriGel® wound care dressing with Vitamin C supplementation

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Length of Time for Wound Closure
Length of time for wound closure will be measured in days
Wound Area Measurements
Wound area measurements in length, width, and depth throughout the course of the study(measured in cm).

Full Information

First Posted
May 4, 2011
Last Updated
November 13, 2017
Sponsor
Susan Hassenbein
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1. Study Identification

Unique Protocol Identification Number
NCT01350102
Brief Title
The Relationship of Hemoglobin A1c and Diabetic Wound Healing
Official Title
The Relationship of Hemoglobin A1c and Diabetic Wound Healing
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Terminated
Why Stopped
study closed due to recruitment problems
Study Start Date
February 2012 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
March 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Susan Hassenbein

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, Type 1, Diabetes, Type 2, Foot Ulcer, Diabetic
Keywords
Adult

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bacitracin wound care dressing alone
Arm Type
Active Comparator
Arm Description
Bacitracin wound care dressing alone
Arm Title
Bacitracin with Vit C
Arm Type
Active Comparator
Arm Description
Bacitracin wound care dressing with Vitamin C supplementation
Arm Title
AmeriGel® wound care dressing alone
Arm Type
Active Comparator
Arm Description
AmeriGel® wound care dressing alone
Arm Title
AmeriGel® with Vit C
Arm Type
Active Comparator
Arm Description
AmeriGel® wound care dressing with Vitamin C supplementation
Intervention Type
Drug
Intervention Name(s)
Bacitracin
Other Intervention Name(s)
Baciguent
Intervention Description
Participants will be treated with Bacitracin to their wound until 100% wound healing, which may take up to 6 months to achieve.
Intervention Type
Drug
Intervention Name(s)
AmeriGel®
Other Intervention Name(s)
Oakin®-based hydrogel, hydrogel containing Oakin®, Oak extract
Intervention Description
Participants will be treated with AmeriGel® to their wound until 100% wound healing, which may take up to 6 months to achieve.
Intervention Type
Dietary Supplement
Intervention Name(s)
Vitamin C
Other Intervention Name(s)
ascorbic acid
Intervention Description
Participants will be treated with Vitamin C supplements 1000 mg daily until 100% wound healing, which may take up to 6 months to achieve
Primary Outcome Measure Information:
Title
Hgb A1c Level
Description
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.
Time Frame
Patients are assessed every 3 months from enrollment through end of study participation, which may be 6 months
Secondary Outcome Measure Information:
Title
Length of Time for Wound Closure
Description
Length of time for wound closure will be measured in days
Time Frame
Patients are assessed every other week (bi-weekly) until 100% wound healing is achieved, which may take up to 6 months
Title
Wound Area Measurements
Description
Wound area measurements in length, width, and depth throughout the course of the study(measured in cm).
Time Frame
Patients are assessed every other week (bi-weekly) until 100% wound healing is achieved, which may take up to 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nell V. Blake, DPM
Organizational Affiliation
Milton S. Hershey Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Penn State Milton S. Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
19638800
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.
Results Reference
background
PubMed Identifier
10326334
Citation
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.
Results Reference
background
PubMed Identifier
4368896
Citation
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.
Results Reference
background
PubMed Identifier
9696906
Citation
Falabella A, Falanga V. Uncommon causes of ulcers. Clin Plast Surg. 1998 Jul;25(3):467-79.
Results Reference
background
PubMed Identifier
8166487
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.
Results Reference
background
PubMed Identifier
8716267
Citation
Maklebust JA, Margolis D. The goodness of measurement. Adv Wound Care. 1996 May-Jun;9(3):6. No abstract available.
Results Reference
background
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.
Results Reference
background
PubMed Identifier
15230830
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. doi: 10.1111/j.1067-1927.2004.0123S1.x.
Results Reference
background
PubMed Identifier
15082349
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. doi: 10.1016/j.burns.2003.10.016.
Results Reference
background
PubMed Identifier
11525849
Citation
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.
Results Reference
background
PubMed Identifier
14764804
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. doi: 10.1210/jc.2003-031371.
Results Reference
background
PubMed Identifier
12200075
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. doi: 10.1016/s1056-8727(01)00217-3.
Results Reference
background
PubMed Identifier
3043987
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. doi: 10.1007/BF02581242.
Results Reference
background
PubMed Identifier
3803737
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. doi: 10.2337/diab.36.3.295.
Results Reference
background
PubMed Identifier
4936077
Citation
Vitamin C and the common cold. Med Lett Drugs Ther. 1970 Dec 25;12(26):105-6. No abstract available.
Results Reference
background
PubMed Identifier
2156081
Citation
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.
Results Reference
background
PubMed Identifier
7304600
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. doi: 10.1093/oxfordjournals.aje.a113243.
Results Reference
background
PubMed Identifier
20424290
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.
Results Reference
background
PubMed Identifier
479447
Citation
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.
Results Reference
background
PubMed Identifier
20598855
Citation
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.
Results Reference
background
PubMed Identifier
12532034
Citation
Smith RG. Validation of Wagner's classification: a literature review. Ostomy Wound Manage. 2003 Jan;49(1):54-62.
Results Reference
background

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The Relationship of Hemoglobin A1c and Diabetic Wound Healing

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