Epidermolysis Bullosa DystrophicaNCT01716169
Treatment of Chronic and Non-Chronic Wounds in Patients With Recessive Dystrophic Epidermolysis Bullosa Using Helicoll Collagen Dressings Versus Standard of Care
A study testing Helicoll in people with Epidermolysis Bullosa Dystrophica and Epidermolysis Bullosa, run by Stanford University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 years and older
- Conditions the study is for
- Epidermolysis Bullosa Dystrophica, Epidermolysis Bullosa
- What is being tested?
- Helicoll
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2012to Nov 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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:
Show all 12Show fewer
- 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.
Who cannot join
- Inability to travel to Stanford for study visits.
- Complicating illness as determined by study investigators to be exclusionary including any infection requiring systemic antibiotics.
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford School of Medicine
Stanford, California, 94305
About this study
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.
- Being tested
- Helicoll, Standard of Care Dressings
- Medical subject headings
- Epidermolysis Bullosa Dystrophica, Epidermolysis Bullosa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HelicollDevice
Helicoll Collagen I Wound Dressing
Standard of Care DressingsDevice
Standard of Care wound dressings (e.g. Vaseline gauze)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Helicoll; Device: Standard of Care Dressings |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2012 (estimated)
- Study startOct 2012
- Primary completionNov 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Epidermolysis Bullosa DystrophicaStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alfred Lane, Stanford University
- Investigators
- Alfred Lane, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01716169
- Sponsor's protocol ID
- 24915
- Status last verified
- Apr 2016
- First submitted
- 25 Oct 2012
- Last updated
- 5 May 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Chronic and Non-Chronic Wounds in Patients With Recessive Dystrophic Epidermolysis Bullosa Using Helicoll Collagen Dressings Versus Standard of Care
- ClinicalTrials.gov ID
- NCT01716169
- Acronym / sponsor ID
- 24915
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 29 Oct 2012 (estimated)
- Results
- Posted 5 May 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Helicoll | Experimental | Device: Helicoll, Device: Standard of Care DressingsHelicoll 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. |
Who may qualify
- Ages
- 7 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (12 listed)
- 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:
- 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.
Key exclusion criteria (5 listed)
- Inability to travel to Stanford for study visits.
- Complicating illness as determined by study investigators to be exclusionary including any infection requiring systemic antibiotics.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HelicollHelicoll Collagen I Wound Dressing | Device | Helicoll |
| Standard of Care DressingsStandard of Care wound dressings (e.g. Vaseline gauze) | Device | Helicoll |
Primary outcome
Percentage of Wound Surface Area Change From Baseline to Week 8
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Enrolling by invitationObservational study
A Long-Term Extension Study for Participants Previously Treated With EB-101 for the Treatment of RDEB
RDEB
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alfred Lane, MD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Helicoll in people with Epidermolysis Bullosa Dystrophica and Epidermolysis Bullosa, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 May 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Wound Surface Area Change From Baseline to Week 8 (time frame: Baseline and Week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2016.