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

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.

Study Overview

• Status: Completed
• Conditions: Epidermolysis Bullosa; Epidermolysis Bullosa Dystrophica
• Intervention / Treatment: Device: Helicoll; Device: Standard of Care Dressings

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Stanford, California, United States, 94305
      • Stanford School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion criteria:

1. 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.
2. Subjects with a clinical diagnosis of RDEB by a dermatologist.

3. 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
4. A parent or legally authorized representative must be willing and able to ensure subject is present for all required study visits (for minor subjects).
5. The subject or caregiver (or a parent or legally authorized representative for subjects under 18) must be able to follow instructions.
6. Subject must be age 7 or older.

Exclusion criteria:

1. Inability to travel to Stanford for study visits.
2. Complicating illness as determined by study investigators to be exclusionary including any infection requiring systemic antibiotics.
3. Presence or history of squamous cell carcinoma at target wound site.
4. Known bovine (cow) or ovine (sheep) sensitivity.
5. Therapy with an investigational agent during the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Helicoll; 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; Helicoll Collagen I Wound Dressing; Device: Standard of Care Dressings; Standard of Care wound dressings (e.g. Vaseline gauze)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Stanford University

Study record dates

Study Major Dates

• Study Start: October 1, 2012
• Primary Completion (Actual): November 1, 2013
• Study Completion (Actual): November 1, 2013

Study Registration Dates

• First Submitted: October 25, 2012
• First Submitted That Met QC Criteria: October 26, 2012
• First Posted (Estimate): October 29, 2012

Study Record Updates

• Last Update Posted (Estimate): May 5, 2016
• Last Update Submitted That Met QC Criteria: April 1, 2016
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Congenital Abnormalities; Genetic Diseases, Inborn; Connective Tissue Diseases; Skin Diseases, Genetic; Skin Diseases, Vesiculobullous; Skin Abnormalities; Collagen Diseases; Epidermolysis Bullosa; Epidermolysis Bullosa Dystrophica
• Other Study ID Numbers: 24915