Leg Ulcers Clinical Trial
Official title:
Mechanisms of Bioengineered Skin in Human Wounds
Verified date | April 2008 |
Source | Roger Williams Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Federal Government |
Study type | Interventional |
This study will look at whether a graft of bioengineered skin (BSC), known commercially as
Apligraf, stimulates the healing process in a person's own skin at the edge of a wound
(known as the edge effect). The information from this study will provide a better
understanding of the ways that grafts of bioengineered skin help the healing of chronic
wounds.
We will assign study participants to either the bioengineered skin group or the control
group. People in the control group will receive compression therapy with a multilayered
compression bandage. We will examine each participant before starting treatment and then
once a week for 24 weeks or until the wound heals. On the first day of treatment (day 0) and
at week 3, week 6, and week 24 (end of treatment) we will take a small tissue sample from
the wound for a biopsy. After the wound is completely healed, we will ask the patient to
return once a month for 6 months to make sure the wound stays healed.
Status | Completed |
Enrollment | 50 |
Est. completion date | August 2005 |
Est. primary completion date | August 2005 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Men or women at least 18 years old - At least one ulcer (wound) greater than or equal to 2 centimeters - Ulcer (wound) present for at least 3 months or greater - Ankle/brachial index > 0.7 - Patient must be ambulatory - Patient must read, understand and sign informed consent Exclusion Criteria: - Medical conditions limiting participation - History of poor compliance, unreliability - History of allergy to bovine collagen - Gangrene, vasculitis, collagen vascular disease osteomyelitis or exposed tendons - Use of systemic steroids/immunosuppressives - History of diabetes mellitus |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Roger Williams Medical Center Dept. of Dermatology & Skin Surgery | Providence | Rhode Island |
Lead Sponsor | Collaborator |
---|---|
Roger Williams Medical Center | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) |
United States,
Badiavas EV, Falanga V. Treatment of chronic wounds with bone marrow-derived cells. Arch Dermatol. 2003 Apr;139(4):510-6. — View Citation
Brem H, Kirsner RS, Falanga V. Protocol for the successful treatment of venous ulcers. Am J Surg. 2004 Jul;188(1A Suppl):1-8. Review. — View Citation
Butmarc J, Yufit T, Carson P, Falanga V. Human beta-defensin-2 expression is increased in chronic wounds. Wound Repair Regen. 2004 Jul-Aug;12(4):439-43. — View Citation
Falanga V, Isaacs C, Paquette D, Downing G, Kouttab N, Butmarc J, Badiavas E, Hardin-Young J. Wounding of bioengineered skin: cellular and molecular aspects after injury. J Invest Dermatol. 2002 Sep;119(3):653-60. — View Citation
Falanga V, Sabolinski M. A bilayered living skin construct (APLIGRAF) accelerates complete closure of hard-to-heal venous ulcers. Wound Repair Regen. 1999 Jul-Aug;7(4):201-7. — View Citation
Kim BC, Kim HT, Park SH, Cha JS, Yufit T, Kim SJ, Falanga V. Fibroblasts from chronic wounds show altered TGF-beta-signaling and decreased TGF-beta Type II receptor expression. J Cell Physiol. 2003 Jun;195(3):331-6. — View Citation
Nahm WK, Philpot BD, Adams MM, Badiavas EV, Zhou LH, Butmarc J, Bear MF, Falanga V. Significance of N-methyl-D-aspartate (NMDA) receptor-mediated signaling in human keratinocytes. J Cell Physiol. 2004 Aug;200(2):309-17. — View Citation
Nahm WK, Zhou L, Falanga V. Sustained ability for fibroblast outgrowth from stored neonatal foreskin: a model for studying mechanisms of fibroblast outgrowth. J Dermatol Sci. 2002 Feb;28(2):152-8. — View Citation
Phillips TJ, Manzoor J, Rojas A, Isaacs C, Carson P, Sabolinski M, Young J, Falanga V. The longevity of a bilayered skin substitute after application to venous ulcers. Arch Dermatol. 2002 Aug;138(8):1079-81. — View Citation
Saap LJ, Donohue K, Falanga V. Clinical classification of bioengineered skin use and its correlation with healing of diabetic and venous ulcers. Dermatol Surg. 2004 Aug;30(8):1095-100. — View Citation
Shen JT, Falanga V. Growth factors, signal transduction, and cellular responses. J Dermatol. 2003 Jan;30(1):5-16. Review. — View Citation
* Note: There are 11 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Measurement and characterization of stimulation of the wound's edges treated with the bioengineered skin construct (BSC) | Measured throughout the study till Week 48 | No | |
Secondary | Response of BSC to injury, including meshed (wounded) and unmeshed BSC | Measured throughout the study till Week 48 | No | |
Secondary | Activation of certain critical cytokines, including IL-1 alpha, IL-6, and TGF-beta | Measured throughout the study till Week 48 | No |
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