Treatment of Chronic and Non-Chronic Wounds in Patients With Recessive Dystrophic Epidermolysis Bullosa Using Helicoll Collagen Dressings Versus Standard of Care

NCT01716169 | Completed Results

• 1 other identifier: 24915
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to test the effectiveness of Helicoll (a collagen wound dressing) in treating chronic and non-chronic wounds of recessive dystrophic epidermolysis bullosa (RDEB) patients. Helicoll will be compared to standard wound dressings.

Conditions

Epidermolysis Bullosa Dystrophica; Epidermolysis Bullosa

Outcome Measures

Primary Outcomes (1)

• Percentage of Wound Surface Area Change From Baseline to Week 8

  Change was assessed in terms of wound surface area, as measured using the ARANZ camera. Week 8 surface area measurement was compared to baseline surface area measurement and percentage in size change was calculated.

  Baseline and Week 8

Study Arms (1)

Helicoll

EXPERIMENTAL

Helicoll will be applied to one chronic wound (approximately 6 months or more duration). Wound designations of "control" or "Helicoll" were placed in a sealed envelope prior to study start. When a subject was enrolled, wounds were identified as "A" or "B". Then the envelope was opened which designated whether A or B would receive control or Helicoll.

Device: Helicoll; Device: Standard of Care Dressings

Interventions

Helicoll DEVICE

Helicoll Collagen I Wound Dressing

Helicoll

Standard of Care Dressings DEVICE

Standard of Care wound dressings (e.g. Vaseline gauze)

Helicoll

Eligibility Criteria

• Age: 7 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Written consent must be obtained from subjects over age 18, or from a parent or legally authorized representative if subject is under 18. Assent will be obtained from subjects age 7 - 17.
• Subjects with a clinical diagnosis of RDEB by a dermatologist.
• Have at least three target wounds that meet the following criteria:
• One chronic wound, of approximately 6 months or more duration. If the subject has an additional chronic wound of similar size and duration, this additional wound will be treated with standard dressings and followed in the study. A wound in an area that consistently heals and then breaks down again will be considered a chronic wound.
• Two non-chronic wounds, of approximately 3 months or less duration, of similar size, and able to be dressed separately. Both wounds should have approximately the same duration.
• All wounds must be:
• Open, and not scabbed or crusted over
• Not actively infected
• Not requiring surgical intervention
• A parent or legally authorized representative must be willing and able to ensure subject is present for all required study visits (for minor subjects).
• The subject or caregiver (or a parent or legally authorized representative for subjects under 18) must be able to follow instructions.
• Subject must be age 7 or older.

You may not qualify if:

• Inability to travel to Stanford for study visits.
• Presence or history of squamous cell carcinoma at target wound site.
• Known bovine (cow) or ovine (sheep) sensitivity.
• Therapy with an investigational agent during the study.

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford School of Medicine

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Epidermolysis Bullosa Dystrophica; Epidermolysis Bullosa

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Dr. Alfred Lane
• Organization: Stanford School of Medicine

atlane@stanford.edu

650 721 7166

Study Officials

• Alfred Lane, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Dermatology and Pediatrics

Study Record Dates

• First Submitted: October 25, 2012
• First Posted: October 29, 2012
• Study Start: October 1, 2012
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2013
• Last Updated: May 5, 2016
• Results First Posted: May 5, 2016

Record last verified: 2016-04

Locations

US (1)