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study closed due to recruitment problems
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bacitracin wound care dressing alone | Active Comparator | Bacitracin wound care dressing alone |
|
| Bacitracin with Vit C | Active Comparator | Bacitracin wound care dressing with Vitamin C supplementation |
|
| AmeriGel® wound care dressing alone | Active Comparator | AmeriGel® wound care dressing alone |
|
| AmeriGel® with Vit C | Active Comparator | AmeriGel® wound care dressing with Vitamin C supplementation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bacitracin | Drug | Participants will be treated with Bacitracin to their wound until 100% wound healing, which may take up to 6 months to achieve. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Wound Area Measurements |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nell V. Blake, DPM | Milton S. Hershey Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Penn State Milton S. Hershey Medical Center | Hershey | Pennsylvania | 17033 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19638800 | Background | 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. | |
| 10326334 | Background |
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Two subjects were screened and enrolled at the clinic site on 2/24/2012 and 1/14/2013.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. Hemoglobin A1c: Hemoglobin A1c levels will be performed and reviewed every three months to assess its relationship to wound healing |
| FG001 | 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. Hemoglobin A1c: Hemoglobin A1c levels will be performed and reviewed every three months to assess its relationship to wound healing 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 |
| FG002 | 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. Hemoglobin A1c: Hemoglobin A1c levels will be performed and reviewed every three months to assess its relationship to wound healing |
| FG003 | 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. Hemoglobin A1c: Hemoglobin A1c levels will be performed and reviewed every three months to assess its relationship to wound healing 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. Hemoglobin A1c: Hemoglobin A1c levels will be performed and reviewed every three months to assess its relationship to wound healing |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Enrollment and 3-month visit A1c levels were obtained for the subject in the Bacitracin with Vit C arm. Enrollment A1c level was obtained for the AmeriGel would care dressing alone. However, this subject withdrew from the study before 3-month A1c level was obtained. | Posted | Number | percentage of hemoglobin | Patients are assessed every 3 months from enrollment through end of study participation, which may be 6 months |
|
enrollment through 20 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. Hemoglobin A1c: Hemoglobin A1c levels will be performed and reviewed every three months to assess its relationship to wound healing |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Infection | Infections and infestations | Non-systematic Assessment | Wound infection at 2 weeks; patient withdrawn from study and provided standard of care treatment to include antibiotics. |
Study terminated due to recruitment issues - only two subjects enrolled in study.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Nell Blake, DPM | Penn State Milton S. Hershey Medical Center | (717) 531-5638 | nblake@pennstatehealth.psu.edu |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| D003924 | Diabetes Mellitus, Type 2 |
| D017719 | Diabetic Foot |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D001414 | Bacitracin |
| C000713747 | oak bark extract |
| D001205 | Ascorbic Acid |
| ID | Term |
|---|---|
| D010456 | Peptides, Cyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D010455 | Peptides |
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|
| AmeriGel® | Drug | Participants will be treated with AmeriGel® to their wound until 100% wound healing, which may take up to 6 months to achieve. |
|
|
| 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 |
|
|
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 |
| 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. |
| 4368896 | 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. |
| 9696906 | Background | Falabella A, Falanga V. Uncommon causes of ulcers. Clin Plast Surg. 1998 Jul;25(3):467-79. |
| 8166487 | 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. |
| 8716267 | Background | Maklebust JA, Margolis D. The goodness of measurement. Adv Wound Care. 1996 May-Jun;9(3):6. No abstract available. |
| 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. |
| 15230830 | 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. |
| 15082349 | 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. |
| 11525849 | 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. |
| 14764804 | 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. |
| 12200075 | 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. |
| 3043987 | 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. |
| 3803737 | 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. |
| 4936077 | Background | Vitamin C and the common cold. Med Lett Drugs Ther. 1970 Dec 25;12(26):105-6. No abstract available. |
| 2156081 | 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. |
| 7304600 | 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. |
| 20424290 | 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. |
| 479447 | 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. |
| 20598855 | 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. |
| 12532034 | Background | Smith RG. Validation of Wagner's classification: a literature review. Ostomy Wound Manage. 2003 Jan;49(1):54-62. |
| BG001 |
| 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. Hemoglobin A1c: Hemoglobin A1c levels will be performed and reviewed every three months to assess its relationship to wound healing 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 |
| BG002 | 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. Hemoglobin A1c: Hemoglobin A1c levels will be performed and reviewed every three months to assess its relationship to wound healing |
| BG003 | 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. Hemoglobin A1c: Hemoglobin A1c levels will be performed and reviewed every three months to assess its relationship to wound healing 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 |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG001 | 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. Hemoglobin A1c: Hemoglobin A1c levels will be performed and reviewed every three months to assess its relationship to wound healing 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 |
| OG002 | 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. Hemoglobin A1c: Hemoglobin A1c levels will be performed and reviewed every three months to assess its relationship to wound healing |
| OG003 | 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. Hemoglobin A1c: Hemoglobin A1c levels will be performed and reviewed every three months to assess its relationship to wound healing 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 |
|
|
| Secondary | Length of Time for Wound Closure | Length of time for wound closure will be measured in days | Only the subject in the Bacitracin with Vit C arm achieved would healing. The subject in the AmeriGel would care dressing alone arm was withdrawn due to lack of healing and infection. | Posted | Number | 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). | The subject enrolled in Bacitracin with Vit C arm had measurements of the wound (width, depth, length) recorded beginning at week 0 through week 20. The subject enrolled in the AmeriGel wound care dressing alone had measurements recorded of the wound (width, depth, length) beginning at week 0 through week 2 before withdrawing from the study. | Posted | Number | cm | Patients are assessed every other week (bi-weekly) until 100% wound healing is achieved, which may take up to 6 months |
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | 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. Hemoglobin A1c: Hemoglobin A1c levels will be performed and reviewed every three months to assess its relationship to wound healing 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 | 0 | 1 | 0 | 1 | 0 | 1 |
| EG002 | 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. Hemoglobin A1c: Hemoglobin A1c levels will be performed and reviewed every three months to assess its relationship to wound healing | 0 | 1 | 0 | 1 | 1 | 1 |
| EG003 | 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. Hemoglobin A1c: Hemoglobin A1c levels will be performed and reviewed every three months to assess its relationship to wound healing 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 | 0 | 0 | 0 | 0 | 0 | 0 |
|
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| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D016523 | Foot Ulcer |
| D007871 | Leg Ulcer |
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D048909 | Diabetes Complications |
| D003929 | Diabetic Neuropathies |
| D000602 |
| Amino Acids, Peptides, and Proteins |
| D013400 | Sugar Acids |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D006880 | Hydroxy Acids |
| D002241 | Carbohydrates |
| Week 0 Length of Wound |
|
| Week 2 Width of Wound |
|
| Week 2 Depth of Wound |
|
| Week 2 Length of Wound |
|
| Week 4 Width of Wound |
|
| Week 4 Depth of Wound |
|
| Week 4 Length of Wound |
|
| Week 6 Width of Wound |
|
| Week 6 Depth of Wound |
|
| Week 6 Length of Wound |
|
| Week 8 Width of Wound |
|
| Week 8 Depth of Wound |
|
| Week 8 Length of Wound |
|
| Week 10 Width of Wound |
|
| Week 10 Depth of Wound |
|
| Week 10 Length of Wound |
|
| Week 12 Width of Wound |
|
| Week 12 Depth of Wound |
|
| Week 12 Length of Wound |
|
| Week 14 Width of Wound |
|
| Week 14 Depth of Wound |
|
| Week 14 Length of Wound |
|
| Week 16 Width of Wound |
|
| Week 16 Depth of Wound |
|
| Week 16 Length of Wound |
|
| Week 18 Width of Wound |
|
| Week 18 Depth of Wound |
|
| Week 18 Length of Wound |
|
| Week 20 Width of Wound |
|
| Week 20 Depth of Wound |
|
| Week 20 Length of Wound |
|