Back to resultsA Observational Study to Evaluate Apligraf(R) in Nonhealing Wounds of Subjects With Epidermolysis Bullosa
Primary Purpose
Epidermolysis Bullosa, Wound Healing
Status
Terminated
Phase
Phase 4
Locations
Switzerland
Study Type
Interventional
Intervention
Apligraf
Sponsored by
About this trial
This is an interventional treatment trial for Epidermolysis Bullosa
Eligibility Criteria
Inclusion Criteria:
- 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.
-
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.
Sites / Locations
- University Hospital Basel
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Active Comparator
Arm Label
no intervention
Apligraf
Arm Description
standard wound care
non adhesive layer with apligraf
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Time
Time until 100 % epithelialization of wound tissue with the absence of drainage (i.e.complete wound closure).
Full Information
NCT ID
NCT01619670
First Posted
June 12, 2012
Last Updated
March 9, 2015
Sponsor
University Hospital, Basel, Switzerland
Collaborators
Organogenesis
1. Study Identification
Unique Protocol Identification Number
NCT01619670
Brief Title
A Observational Study to Evaluate Apligraf(R) in Nonhealing Wounds of Subjects With Epidermolysis Bullosa
Official Title
A Prospective Single Center Within Subject Controlled Observational Study to Evaluate Apligraf(R) in Nonhealing Wounds of Subjects With Epidermolysis Bullosa
Study Type
Interventional
2. Study Status
Record Verification Date
March 2015
Overall Recruitment Status
Terminated
Study Start Date
June 2012 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
January 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Basel, Switzerland
Collaborators
Organogenesis
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epidermolysis Bullosa, Wound Healing
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
3 (Actual)
8. Arms, Groups, and Interventions
Arm Title
no intervention
Arm Type
No Intervention
Arm Description
standard wound care
Arm Title
Apligraf
Arm Type
Active Comparator
Arm Description
non adhesive layer with apligraf
Intervention Type
Device
Intervention Name(s)
Apligraf
Intervention Description
non adhesive layer
Primary Outcome Measure Information:
Title
Proportion of wounds
Description
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
Secondary Outcome Measure Information:
Title
Time
Description
Time until 100 % epithelialization of wound tissue with the absence of drainage (i.e.complete wound closure).
Time Frame
until 100% epithelialization
Other Pre-specified Outcome Measures:
Title
Pain
Description
Reduction of intensity of pain
Time Frame
Study duration
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
-
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andreas Arnold, MD
Organizational Affiliation
University Hospital Basel, Dep. Dermatology and Venereology, Basel/Switzerland
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Basel
City
Basel
ZIP/Postal Code
4031
Country
Switzerland
12. IPD Sharing Statement
Learn more about this trial
A Observational Study to Evaluate Apligraf(R) in Nonhealing Wounds of Subjects With Epidermolysis Bullosa
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