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

Stanford University

Status: Completed

Conditions: Epidermolysis Bullosa Dystrophica; Epidermolysis Bullosa

Treatments: Device: Helicoll; Device: Standard of Care Dressings

Study type: Interventional

Funder types: Other

Identifiers

NCT01716169

24915

Details and patient eligibility

About

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.

Enrollment: 10 patients

Sex: All

Ages: 7+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Helicoll

Experimental group

Description:

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.

Treatment:

Device: Helicoll

Device: Standard of Care Dressings