A Observational Study to Evaluate Apligraf(R) in Nonhealing Wounds of Subjects With Epidermolysis Bullosa

NCT01619670 | Terminated Phase 4

• 1 other identifier: EKBB 235/11
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Epidermolysis Bullosa; Wound Healing

Outcome Measures

Primary Outcomes (1)

• 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.

  through study week 12

Secondary Outcomes (1)

• Time

  until 100% epithelialization

Other Outcomes (1)

• Pain

  Study duration

Study Arms (2)

no intervention

NO INTERVENTION

standard wound care

Apligraf

ACTIVE COMPARATOR

non adhesive layer with apligraf

Device: Apligraf

Interventions

Apligraf DEVICE

non adhesive layer

Apligraf

Eligibility Criteria

• Age: 2 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject is between 2 and 65 years of age.
• Subject with clinical confirmed diagnosis of EB.
• Subject has at least two lesions, if in a situation with two non-adjacent EB lesions, at least 4 cm apart.
• Subject with EB lesions at least 2 cm2 present for at least 3weeks. For the purposes of this study, a lesion is defined as a wound resulting from a post blister erosion.
• Subject who is a female of child-bearing potential (females \>10 years of age) must have a documented negative urine or serum pregnancy test. Sexually active females must be practicing a medically proven form of contraception during the course of the study period.
• Subject or legal guardian must have read, understood and signed an institutional review board (IRB) approved Informed Consent Form or Assent Form.
• Subject and/or legal guardian must be able and willing to follow study procedures and instructions.

You may not qualify if:

• \. 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.
• \. Subject with uncontrolled diabetes mellitus (glycosylated HbA1C \> 10%), cancer (biopsy confirmed active malignancy), or positive HIV test.
• \. Subject is a child (\<18 years of age) who is currently receiving or has received oral steroid therapy exceeding a total daily dose of 0.5mg/kg for more than two weeks, radiation or other immuno-suppressive therapy which would interfere with wound healing within the past four weeks.
• \. Subject is an adult (\>18 years of age) who is currently receiving or has received chronic high dose steroid therapy exceeding a total daily dose of 20mg for more than two weeks, radiation or other immuno-suppressive therapy which would interfere with wound healing within the past four weeks.
• \. Subject who is currently on or has received topical steroidal therapy within 30 days before screening. Inhaled steroids are allowed.
• \. Subject with the presence of acute infections in the areas intended for treatment.
• \. Known hypersensitivity to bovine collagen or to the components of the Apligraf agarose shipping medium.
• \. Subject who is lactating or pregnant (hCG positive as determined by lab testing).
• \. Subject enrolled in any wound or investigational device study for any disease within the past four weeks.
• \. Subject who has received an investigational drug or biological treatment within three months.
• \. Subject with a history of alcohol or substance abuse within the previous year, which could interfere with study compliance such as inability to attend scheduled study visits or compliance with home dressing changes.
• \. Subject who, in the opinion of the investigator, for any reason other than those listed above, will not be able to complete the study per protocol.

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead
• Organogenesis: collaborator

Study Sites (1)

University Hospital Basel

Basel, 4031, Switzerland

Location

MeSH Terms

Conditions

Epidermolysis Bullosa

Condition Hierarchy (Ancestors)

Skin Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin Diseases, Genetic; Genetic Diseases, Inborn; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Vesiculobullous

Study Officials

• Andreas Arnold, MD

  University Hospital Basel, Dep. Dermatology and Venereology, Basel/Switzerland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2012
• First Posted: June 14, 2012
• Study Start: June 1, 2012
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: March 10, 2015

Record last verified: 2015-03

Locations

CH (1)