A Phase 4 interventional study of Apligraf in Epidermolysis Bullosa and Wound Healing, sponsored by University Hospital, Basel, Switzerland. Terminated at 1 site in Switzerland. Open to participants aged 2 Years to 65 Years. Per ClinicalTrials.gov, last updated 2015-03-10.
Sponsored by University Hospital, Basel, Switzerland · Phase 4, Interventional, and Treatment
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.
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.
126 studies on the registry are indexed under Epidermolysis Bullosa; 23 are open to participants now.
This study's enrollment of 3 is below the median of 11 across 95 interventional studies indexed under Epidermolysis Bullosa.
Browse Epidermolysis Bullosa studies →University Hospital, Basel, Switzerland is the lead sponsor of 968 studies on the registry; 191 are open to participants now.
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Exclusion Criteria:
Subject whose lesion has healed 20% or greater in area from post debridement (if applicable) Baseline Screen (Visit 1) to post debridement Day 0 (Visit 2) as determined by wound tracings.
standard wound care
non adhesive layer with apligraf
Device: Apligraf
non adhesive layer
Proportion of wounds
Proportion of wounds first achieving 100 % epithelialization of tissue with the absence of drainage (i.e. complete wound closure) through study week 12.
Time frame: through study week 12
Time
Time until 100 % epithelialization of wound tissue with the absence of drainage (i.e.complete wound closure).
Time frame: until 100% epithelialization
Pain
Reduction of intensity of pain
Time frame: Study duration
This study is terminated, as verified in Mar 2015. You cannot join it, but the record below documents what was studied.
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University Hospital, Basel, Switzerland