A Observational Study to Evaluate Apligraf(R) in Nonhealing Wounds of Subjects With Epidermolysis Bullosa
Epidermolysis Bullosa (EB) is a very rare disease, with a severe impact on the life of the patient and the caregiver. Epidermolysis Bullosa (EB) comprises a group of genetically determined skin fragility disorders characterized by blistering of the skin and mucosae following mild mechanical trauma. There is no specific proven treatment for any form of EB, and the mainstay of clinical management is based on protection and avoidance of provoking factors. Chronic nonhealing erosions and ulcers have been treated with conventional split-thickness skin grafts. Alternatively some patients may benefit from the use of autologous or allogeneic cultured keratinocyte grafts.
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Prospective Single Center Within Subject Controlled Observational Study to Evaluate Apligraf(R) in Nonhealing Wounds of Subjects With Epidermolysis Bullosa|
- Proportion of wounds [ Time Frame: through study week 12 ] [ Designated as safety issue: No ]Proportion of wounds first achieving 100 % epithelialization of tissue with the absence of drainage (i.e. complete wound closure) through study week 12.
- Time [ Time Frame: until 100% epithelialization ] [ Designated as safety issue: No ]Time until 100 % epithelialization of wound tissue with the absence of drainage (i.e.complete wound closure).
- Pain [ Time Frame: Study duration ] [ Designated as safety issue: No ]Reduction of intensity of pain
|Study Start Date:||June 2012|
|Study Completion Date:||January 2015|
|Primary Completion Date:||January 2015 (Final data collection date for primary outcome measure)|
No Intervention: no intervention
standard wound care
Active Comparator: Apligraf
non adhesive layer with apligraf
non adhesive layer
Apligraf is a living bilayered cell therapy product. Apligraf is constructed of Type I bovine collagen. The mechanism of action of Apligraf is still unknown. No clinical evidence of rejection of Apligraf was observed when placed on acute or chronic wounds. Apligraf has been suggested to act as a "smart" material for wound healing by interacting with the surrounding environment to promote healing. It provides components with multiple actions, interacts with wounds in biological and physical ways, and appears to adapt to the wound environment and probably produces numerous pro-healing cytokines. The purpose of this study is to evaluate the use of Apligraf for the treatment of nonhealing wounds in subjects with epidermolysis bullosa. Apligraf will be evaluated for efficacy and safety compared to a conventional nonadherent dressing. The study is a pivotal, single center, within subject controlled observational trial in which the rate of wound healing, recurrence of EB lesions, subject report of pain will be compared to wounds treated with Control treatment. Subjects between 2 and 65 years of age, inclusive, with epidermolysis bullosa lesions will be screened for this study. For each subject at least two designated treatment sites will be selected. In case of two comparable treatment sites the most right side will receive Apligraf and the most left side will receive control. Efficacy will be assessed by clinical observations, wound tracings and photographs.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01619670
|University Hospital Basel|
|Basel, Switzerland, 4031|
|Principal Investigator:||Andreas Arnold, MD||University Hospital Basel, Dep. Dermatology and Venereology, Basel/Switzerland|