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Proof of Concept Study for a Dressing Glove

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ClinicalTrials.gov Identifier: NCT03241628
Recruitment Status : Completed
First Posted : August 7, 2017
Last Update Posted : February 15, 2018
Sponsor:
Collaborators:
King's College London
Cardiff University
University of Surrey
Information provided by (Responsible Party):
Guy's and St Thomas' NHS Foundation Trust

Brief Summary:

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.


Condition or disease Intervention/treatment
Epidermolysis Bullosa Dystrophica Device: Dressing Glove

  Show Detailed Description

Study Type : Observational
Actual Enrollment : 14 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Generation and Evaluation of Hand Therapy Devices for Epidermolysis Bullosa (GLOVE Project): Proof of Concept Study for a Dressing Glove
Actual Study Start Date : May 3, 2017
Actual Primary Completion Date : January 31, 2018
Actual Study Completion Date : January 31, 2018


Group/Cohort Intervention/treatment
Dressing Glove

Fitting bespoke dressing gloves (viscose Class 1 medical device) and evaluating dressing glove performance in the management of blisters using patient recorded outcome measures. The aim is to obtain proof of concept data for the dressing glove as an acceptable alternative to patch work dressings held in place with bandages.

The study protocol recommends a daily change of the dressing glove but the patients also contribute their preference for frequency of dressing changes.

Device: Dressing Glove
Viscose dressing glove




Primary Outcome Measures :
  1. Effectiveness of disposable dressing glove compared with normal dressings and bandages [ Time Frame: 14 weeks ]
    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.


Secondary Outcome Measures :
  1. Compatibility with the SkinniesTM Web Spacer glove [ Time Frame: 14 weeks ]
    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


Other Outcome Measures:
  1. Device preference [ Time Frame: 14 weeks ]
    Would they like to continue to wear the dressing glove



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Ages Eligible for Study:   1 Year and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adults and children with RDEB and hand deformaties
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03241628


Locations
United Kingdom
King's College London
London, United Kingdom, SE1 8WA
Sponsors and Collaborators
Guy's and St Thomas' NHS Foundation Trust
King's College London
Cardiff University
University of Surrey
Investigators
Principal Investigator: Patricia Grocott, PhD NIHR i4i

Responsible Party: Guy's and St Thomas' NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT03241628     History of Changes
Other Study ID Numbers: 17/LO/0420
First Posted: August 7, 2017    Key Record Dates
Last Update Posted: February 15, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Guy's and St Thomas' NHS Foundation Trust:
Skin blisters
Finger webbing
Finger contracture
Hand contracture

Additional relevant MeSH terms:
Epidermolysis Bullosa
Epidermolysis Bullosa Dystrophica
Skin Abnormalities
Congenital Abnormalities
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases
Skin Diseases, Vesiculobullous
Collagen Diseases
Connective Tissue Diseases