Condition category
Nutritional, Metabolic, Endocrine
Date applied
28/03/2011
Date assigned
28/03/2011
Last edited
15/04/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
About 15% of people with diabetes at some stage will develop chronic foot ulcers (long-lasting sores). Only two-thirds will heal without some form of surgery and in about one case in 12 the limb is lost through amputation. The factors which cause ulcers, and which delay their healing, are multiple, and there are no specific treatments to improve outcome. Ulcers which occur on the heel pose a particular problem. Recently, some centres have started to use a soft, lightweight, fibreglass cast which is moulded to the heel of the patient. The cast is cheap to make and takes only minutes to fashion, and is incorporated into the dressings which cover the heel. The early evidence is that this device both increases the rate of healing and (in those who have pain in the heel) reduces discomfort. The aim of this study is to prove the effectiveness of this simple and cheap new device.

Who can participate?
Patients aged 18 or over with type 1 or type 2 diabetes and an ulcer of the heel.

What does the study involve?
Participants are randomly allocated to one of two groups, to either have their heel ulcer managed according to current recommendations, or to also have a lightweight fibreglass heel cast incorporated into the dressing which is applied to their heel. Dressings are replaced at least twice a week, and this is done by their regular nurse or a member of the family according to usual practice. Those who have a heel cast have it replaced as often as is necessary. Both groups are otherwise managed according to recommended guidance. We wish to determine whether the use of the heel cast results in an increased number of heel ulcers being healed by 6 months. Local pain, mood and function are also compared in each group, as well as adverse events and costs.

What are the possible benefits and risks of participating?
Not provided at time of registration

Where is the study run from?
Nottingham Clinical Trials Unit (UK)

When is the study starting and how long is it expected to run for?
February 2011 to June 2015

Who is funding the study?
NIHR Health Technology Assessment Programme - HTA (UK)

Who is the main contact?
Vivienne Savage
vivienne.turtle-savage@nottingham.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Mrs Vivienne Savage

ORCID ID

Contact details

Nottingham Clinical Trials Unit
Derby Road
Nottingham
NG7 2UH
United Kingdom
-
vivienne.turtle-savage@nottingham.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

9299; HTA 09/01/53

Study information

Scientific title

Evaluation of lightweight fibreglass heel casts in the management of ulcers of the heel in diabetes: a randomised controlled trial

Acronym

DRN 528

Study hypothesis

About 15% of all people with diabetes get foot ulcers and is the source of considerable cost and suffering. Heel ulcers present particular difficulties and may take up to three times as long to heal than ulcers elswehere on the foot even if they do heal. Heel ulcers in diabetes also differ from ulcers elsewhere on the foot in that they are frequently painful. There are currently no specific interventions which have been shown to improve the outcome. However a small number of specialists in UK have recently started to use lightweight, fibreglass heel casts and there is uncontrolled observational evidence that these devices result in both a reduced time to healing and a prompt improvement in pain and discomfort. The mechanism for any positive effect is not known but may relate to the reduction of shearing and stretching forces applied to the surface of the ulcer. These heel casts take approximately 15 minutes to make and can be easily fashioned in a domiciliary setting. They are applied over the primary wound dressing, and held in place with an outer dressing, being saved and reused each time the dressing is changed. They are replaced when stained, damaged or lost, and can often be worn inside shoes. Health care professionals can be trained in their use in approximately 30 minutes, and the material cost of each cast is approximately £7. Casts need to be replaced on average each three weeks. The purpose of the proposed study is to confirm the effectiveness and cost implications of this simple intervention, by randomly allocating patients with diabetes and ulcers of the heel either to standard care (according to best practice) or standard care and a fibreglass heel cup. The primary outcome will be the proportion of patients with healed ulcers after 24 weeks.

Further details can be found at: http://www.nets.nihr.ac.uk/projects/hta/090153
Protocol can be found at: http://www.nets.nihr.ac.uk/__data/assets/pdf_file/0010/53110/PRO-09-01-53.pdf

Ethics approval

Leeds West Research Ethics Committee, 16/02/2011, ref: 10/H1307/124

Study design

Randomised; Interventional; Design type: Treatment

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details below to request a patient information sheet

Condition

Topic: Diabetes Research Network; Subtopic: Both; Disease: Diabetic foot

Intervention

Heel cast, fibreglass heel casts in the management of ulcers of the heel in diabetes; control (usual care) versus usual care with the addition of a fibreglass heel cast.

Total study duration is 60 months, follow-up is 12 and 24 weeks (post healing). Single Randomisation only

Intervention type

Other

Phase

Phase III

Drug names

Primary outcome measures

Percentage of all ulcers healed at 24 weeks (6 months)

Secondary outcome measures

1. Ulcer-related outcomes - Time to healing, change in ulcer area, adverse events (including infection, major and minor amputation) and ulcer recurrence
2. Patient-related outcomes - Local pain (visual analogue scale), mood and function (EQ-5D), Cardiff Wound Impact Schedule (CWIS) and survival
3. Health economic analysis

Overall trial start date

01/02/2011

Overall trial end date

30/06/2015

Reason abandoned

Eligibility

Participant inclusion criteria

1. Type 1 or type 2 diabetes mellitus
2. Age 18 years or over
3. An ulcer of the heel (below the malleoli and affecting the skin overlying the calcaneum) of national pressure ulcer advisory panel-european pressure ulcer advisory panel (NPUAPEPUAP) Grade 24, which has been present for two or more weeks. If there is more than one heel ulcer, one will be selected as the index ulcer and this will be generally the largest or the most clinically significant.
4. Subjects who are both able and willing to give written informed consent
Target Gender: Male & Female ; Lower Age Limit 18 years

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 529; UK Sample Size: 529

Participant exclusion criteria

1. Frailty or disability which would mean that participation in the study might have an adverse effect of patient well being and mood
2. The need for any offloading device to be nonremovable
3. The likelihood of protocol violation because of planned travel
4. Pregnancy or the possibility of pregnancy
5. Those who withhold consent
6. Active participation in another study of a wound care product
7. The use of topical negative pressure or application of larvae to the index heel ulcer

Recruitment start date

01/02/2011

Recruitment end date

30/06/2015

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Nottingham Clinical Trials Unit
Nottingham
NG7 2UH
United Kingdom

Sponsor information

Organisation

Nottingham University Hospitals NHS Trust (UK)

Sponsor details

Hucknall Road
Nottingham
NG5 1PB
United Kingdom

Sponsor type

Government

Website

Funders

Funder type

Government

Funder name

Health Technology Assessment Programme, Grant Codes: 09/01/53

Alternative name(s)

NIHR Health Technology Assessment Programme, HTA

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

01/02/2017

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2014 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/25428268

Publication citations

Additional files

Editorial Notes

15/04/2016: Plain English summary added.