Epidermolysis Bullosa, Epidermolysis Bullosa Dystrophica
Conditions
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.
Interventions
DEVICEHelicoll
Helicoll Collagen I Wound Dressing
DEVICEStandard of Care Dressings
Standard of Care wound dressings (e.g. Vaseline gauze)
Sponsors
Stanford University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
7 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Recruitment details
Recruitment from EB Clinic patients, organization website
Participants by arm
| Arm | Count |
|---|---|
| Helicoll - Chronic Wound Helicoll will be applied to one chronic wound (approximately 6 months or more duration)
Helicoll: Helicoll Collagen I Wound Dressing | 10 |
| Total | 10 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
| Overall Study | inconsistent dressing application | 1 |
| Overall Study | Lost to Follow-up | 1 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Helicoll - Chronic Wound |
|---|---|
| Age, Categorical <=18 years | 8 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 2 Participants |
| Age, Continuous | 15.6 years STANDARD_DEVIATION 5.6 |
| Region of Enrollment United States | 10 participants |
| Sex: Female, Male Female | 5 Participants |
| Sex: Female, Male Male | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 1 / 10 | 0 / 7 |
| serious Total, serious adverse events | 0 / 10 | 0 / 7 |
Outcome results
Primary
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.
Time frame: Baseline and Week 8
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Helicoll - Chronic Wound | Percentage of Wound Surface Area Change From Baseline to Week 8 | -63 percentage of wound surface area |
| Standard of Care Dressing - Chronic Wound | Percentage of Wound Surface Area Change From Baseline to Week 8 | -8.1 percentage of wound surface area |