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

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ClinicalTrials.gov Identifier: NCT01619670
Recruitment Status : Terminated
First Posted : June 14, 2012
Last Update Posted : March 10, 2015
Sponsor:
Collaborator:
Organogenesis
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland

Study Description
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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.

Condition or disease Intervention/treatment Phase
Epidermolysis Bullosa Wound Healing Device: Apligraf Phase 4

Detailed Description:
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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : June 2012
Actual Primary Completion Date : January 2015
Actual Study Completion Date : January 2015

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Arms and Interventions
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Arm Intervention/treatment
No Intervention: no intervention
standard wound care
Active Comparator: Apligraf
non adhesive layer with apligraf
 Device: Apligraf
non adhesive layer


Outcome Measures
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Primary Outcome Measures :
  1. Proportion of wounds [ Time Frame: through study week 12 ]
    Proportion of wounds first achieving 100 % epithelialization of tissue with the absence of drainage (i.e. complete wound closure) through study week 12.


Secondary Outcome Measures :
  1. Time [ Time Frame: until 100% epithelialization ]
    Time until 100 % epithelialization of wound tissue with the absence of drainage (i.e.complete wound closure).


Other Outcome Measures:
  1. Pain [ Time Frame: Study duration ]
    Reduction of intensity of pain


Eligibility Criteria
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Ages Eligible for Study:   2 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subject is between 2 and 65 years of age.
  2. Subject with clinical confirmed diagnosis of EB.
  3. Subject has at least two lesions, if in a situation with two non-adjacent EB lesions, at least 4 cm apart.
  4. 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.
  5. 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.
  6. Subject or legal guardian must have read, understood and signed an institutional review board (IRB) approved Informed Consent Form or Assent Form.

  7. Subject and/or legal guardian must be able and willing to follow study procedures and instructions.

    -

Exclusion Criteria:

  • 1. 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.

    2. Subject with uncontrolled diabetes mellitus (glycosylated HbA1C > 10%), cancer (biopsy confirmed active malignancy), or positive HIV test.

    3. 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.

    4. 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.

    5. Subject who is currently on or has received topical steroidal therapy within 30 days before screening. Inhaled steroids are allowed.

    6. Subject with the presence of acute infections in the areas intended for treatment.

    7. Known hypersensitivity to bovine collagen or to the components of the Apligraf agarose shipping medium.

    8. Subject who is lactating or pregnant (hCG positive as determined by lab testing).

    9. Subject enrolled in any wound or investigational device study for any disease within the past four weeks.

    10. Subject who has received an investigational drug or biological treatment within three months.

    11. 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.

    12. 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.

Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01619670


Locations
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Switzerland
University Hospital Basel
Basel, Switzerland, 4031
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Organogenesis
Investigators
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Principal Investigator: Andreas Arnold, MD University Hospital Basel, Dep. Dermatology and Venereology, Basel/Switzerland
More Information
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Responsible Party: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT01619670    
Other Study ID Numbers: EKBB 235/11
First Posted: June 14, 2012    Key Record Dates
Last Update Posted: March 10, 2015
Last Verified: March 2015
Additional relevant MeSH terms:
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Epidermolysis Bullosa
Wounds and Injuries
Skin Abnormalities
Congenital Abnormalities
 Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases
Skin Diseases, Vesiculobullous