Epidermolysis Bullosa Dystrophica Clinical Trial
Official title:
Generation and Evaluation of Hand Therapy Devices for Epidermolysis Bullosa (GLOVE Project): Proof of Concept Study for a Dressing Glove
Verified date | February 2018 |
Source | Guy's and St Thomas' NHS Foundation Trust |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Epidermolysis Bullosa (EB) is a group of genetic conditions causing extensive, painful skin
blisters and wounds. Four main types of EB are recognised, which all affect the hands but
those patients usually requiring hand therapy interventions have Recessive Dystrophic EB
(RDEB).
The proof of concept study is part of the GLOVE (Generation and evaLuation Of hand therapy
deVices for Epidermolysis bullosa) project. The project aims (i) to develop two hand therapy
devices; a disposable dressing glove and splint glove to manage blisters, wounds and
contractures that occur on the hands of people with RDEB (ii) to design and implement the
Hand Therapy Online (HTO) electronic patient record system and (iii) to determine the cost
effectiveness of the devices and the HTO system.
The proof of concept study focuses on testing the clinical performance and cost effectiveness
of the dressing glove when compared with conventional dressings.
Recruited GLOVE participants will be invited to participate in the 14 week study, conducted
using a quasi-experimental, n-of-1 research design. Patients who have not participated in
GLOVE will also be invited to join. Participants will be asked to follow their usual dressing
regime for six weeks. At week 7, they will be given several pairs of dressing gloves to
replace their usual dressings, or starting to wear the glove if they avoid dressings normally
and familiarise themselves. If participants usually wear their gloves to maintain their web
spaces, they will wear these on top of the dressing glove to help assess compatibility.
Participants will provide feedback twice a week from week 7 on the dressing glove by
answering 12 questions (TELER indicators) validated in the Pilot study (REC no: 16/LO/1046)
using the HTO system. Data from the HTO system will be used by the Health Economist to
determine the dressing glove and HTO's cost effectiveness.
Status | Completed |
Enrollment | 14 |
Est. completion date | January 31, 2018 |
Est. primary completion date | January 31, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 1 Year and older |
Eligibility |
Inclusion Criteria: 1. Adults (over the age of seventeen) with RDEB who use or have used dressings and bandages on their hands. 2. Parents/carers of adults over the age of 17 with RDEB who use or have used dressings and bandages on their hands. 3. Parents/carers of babies, children and young people (up to the age of 17) with RDEB who use or have used dressings and bandages on their hands. 4. Babies, children and young people (age 1-17 years) with RDEB who use or have used dressings and bandages on their hands. 5. Able to communicate in English, verbally and in writing 6. Able to make an informed decision to participate and to give written consent 7. Not participating in concurrent clinical studies Exclusion Criteria: 1. Babies aged less than 1 year old 2. Not able to communicate in English, verbally and in writing 3. Not able to make an informed decision to participate and to give written consent 4. Participating in concurrent clinical studies |
Country | Name | City | State |
---|---|---|---|
United Kingdom | King's College London | London |
Lead Sponsor | Collaborator |
---|---|
Guy's and St Thomas' NHS Foundation Trust | Cardiff University, King's College London, University of Surrey |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Device preference | Would they like to continue to wear the dressing glove | 14 weeks | |
Primary | Effectiveness of disposable dressing glove compared with normal dressings and bandages | Dressing glove performance against pre-determined performance criteria (12 patient recorded outcome measures on the HTO system) at the individual and group level with each participant acting as their own control. | 14 weeks | |
Secondary | Compatibility with the SkinniesTM Web Spacer glove | Determination of the compatibility of disposable dressing glove with the SkinniesTM Web Spacer glove or any other make of glove used by the participants with RDEB to maintain their web spaces | 14 weeks |
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