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

Not Applicable

Completed

• Conditions: Epidermolysis Bullosa Dystrophica; Epidermolysis Bullosa
• Interventions: Device: Helicoll; Device: Standard of Care Dressings

• Registration Number: NCT01716169
• Lead Sponsor: Stanford University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-10
• Study First Submitted: 2012-10-25
• Study First Submitted QC: 2012-10-26
• Study First Posted: 2012-10-29
• Primary Completion: 2013-11
• Study Completion: 2013-11
• Results First Submitted: 2015-05-22
• Status Verified: 2016-04
• Results First Submitted QC: 2016-04-01
• Last Update Submitted: 2016-04-01
• Results First Posted: 2016-05-05
• Last Update Posted: 2016-05-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Helicoll	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.
Helicoll	Standard of Care Dressings	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.

Primary Outcome Measures

Name	Time	Method
Percentage of Wound Surface Area Change From Baseline to Week 8	Baseline and 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.

Trial Locations

Locations (1)

Stanford School of Medicine; 🇺🇸 Stanford, California, United States