Bioengineered Skin and Wound Healing

NCT00007280 | Completed Phase 1

• 2 other identifiers: R01AR046557NIAMS-060
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Leg Ulcers

Keywords

Bioengineered skin; Venous leg ulcer

Outcome Measures

Primary Outcomes (1)

• Measurement and characterization of stimulation of the wound's edges treated with the bioengineered skin construct (BSC)

  Measured throughout the study till Week 48

Secondary Outcomes (2)

• Response of BSC to injury, including meshed (wounded) and unmeshed BSC

  Measured throughout the study till Week 48

• Activation of certain critical cytokines, including IL-1 alpha, IL-6, and TGF-beta

  Measured throughout the study till Week 48

Interventions

Bioengineered skin DEVICE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Roger Williams Medical Center: lead
• National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS): collaborator

Study Sites (1)

Roger Williams Medical Center Dept. of Dermatology & Skin Surgery

Providence, Rhode Island, 02908, United States

Location

Related Publications (11)

• 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. doi: 10.1046/j.1524-475x.1999.00201.x.

  PMID: 10781211 BACKGROUND

• 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. doi: 10.1046/j.1523-1747.2002.01865.x.

  PMID: 12230509 BACKGROUND

• 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. doi: 10.1016/s0923-1811(01)00157-8.

  PMID: 11858954 BACKGROUND

• 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. doi: 10.1001/archderm.138.8.1079.

  PMID: 12164746 BACKGROUND

• Badiavas EV, Falanga V. Treatment of chronic wounds with bone marrow-derived cells. Arch Dermatol. 2003 Apr;139(4):510-6. doi: 10.1001/archderm.139.4.510.

  PMID: 12707099 BACKGROUND

• 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. doi: 10.1002/jcp.10301.

  PMID: 12704642 BACKGROUND

• Shen JT, Falanga V. Growth factors, signal transduction, and cellular responses. J Dermatol. 2003 Jan;30(1):5-16.

  PMID: 12598704 BACKGROUND

• 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. doi: 10.1002/jcp.20010.

  PMID: 15174101 BACKGROUND

• Brem H, Kirsner RS, Falanga V. Protocol for the successful treatment of venous ulcers. Am J Surg. 2004 Jul;188(1A Suppl):1-8. doi: 10.1016/S0002-9610(03)00284-8.

  PMID: 15223495 BACKGROUND

• 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. doi: 10.1111/j.1524-4725.2004.30334.x.

  PMID: 15274699 BACKGROUND

• 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. doi: 10.1111/j.1067-1927.2004.12405.x.

  PMID: 15260809 BACKGROUND

MeSH Terms

Conditions

Leg Ulcer; Varicose Ulcer

Condition Hierarchy (Ancestors)

Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Varicose Veins; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Vincent Falanga, MD

  Roger Williams Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2000
• First Posted: December 18, 2000
• Study Start: October 1, 2000
• Primary Completion: August 1, 2005
• Study Completion: August 1, 2005
• Last Updated: August 2, 2013

Record last verified: 2008-04

Locations

US (1)