Development of wound healing therapies: a randomised controlled single-blind prospective pilot study for the use of autologous keratinocytes on a transfer dressing (TranCell) in the treatment of diabetic ulcers

ISRCTN ISRCTN14871374
DOI https://doi.org/10.1186/ISRCTN14871374
Secondary identifying numbers 068906
Submission date
22/07/2005
Registration date
22/07/2005
Last edited
04/02/2016
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Background and study aims
Diabetic foot ulcers are painful red sores that can develop on the feet of people with type 1 or type 2 diabetes. The aim of this study is to find out whether the rate of healing of diabetic foot ulcers can be improved using the patient’s own skin cells, grown in a laboratory (cultured) and delivered on a transfer dressing.

Who can participate?
Patients aged over 18 with diabetic foot ulcers that are resistant to conventional treatment.

What does the study involve?
Participants are randomly allocated to be treated with either a dressing containing cultured skin cells (active treatment) or a placebo (dummy) dressing for 6 weeks. All participants then receive active treatments for a maximum of 12 treatments where required.

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

Where is the study run from?
Royal Hallamshire Hospital, Sheffield, UK

When is the study starting and how long is it expected to run for?
October 2002 to September 2005

Who is funding the study?
Wellcome Trust (UK)

Who is the main contact?
Dr Simon Heller
s.heller@sheffield.ac.uk

Contact information

Dr Simon Heller
Scientific

Academic Unit of Diabetes, Endocrinology and Metabolism
M Floor
Royal Hallamshire Hospital
Glossop Road
Sheffield
S10 2JF
United Kingdom

Phone +44 (0)114 271 2162
Email s.heller@sheffield.ac.uk

Study information

Study designRandomised controlled single-blind prospective pilot study
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific titleDevelopment of wound healing therapies: a randomised controlled single-blind prospective pilot study for the use of autologous keratinocytes on a transfer dressing (TranCell) in the treatment of diabetic ulcers
Study objectivesThis is a pilot study designed to determine whether the use of tranCell in addition to standard care improves the rate of healing of uncomplicated neuropathic diabetic foot ulcers compared to standard care alone.
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedDiabetic foot ulcer
InterventionThis will be a pilot study, undertaken in three centres. It will be randomised with control patients receiving placebo dressings for the initial, single (patient) blind phase of six weeks. The second phase will be open and all patients will receive active dressings.
Intervention typeOther
Primary outcome measure1. Rate of ulcer healing over six and 12 weeks
2. The rate of reduction will be assessed by % reduction in ulcer area and by the decline in absolute area (mm²)
3. % ulcers healed (full epithelialisation) at six and 12 weeks
4. % healed ulcers that remain healed at 12 weeks  
Secondary outcome measuresNo secondary outcome measures
Overall study start date01/10/2002
Completion date30/09/2005

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants16
Key inclusion criteria1. Patients with type one or type two diabetes of any age over 18 years who give written informed consent
2. The presence of one or more uncomplicated pure neuropathic foot ulcers of at least four weeks duration with a cross sectional area of 0.5 cm^2 or greater on the toes or plantar surface of the forefoot
3. If patients have more than one suitable ulcer at the time of entry into the study, the ulcer of the greatest duration will be selected as the index ulcer for the study
Key exclusion criteria1. Those who withhold, or are unable to give a written informed consent
2. Those with ischaemic toes or both foot pulses (dorsalis pedis, posterior tibial) impalpable on the affected foot
3. Those who are allergic to the antibiotics used in the culture of the cells (penicillin, streptomycin, or amphotericin)
4. Those unable to attend for dressing changes at the required frequency
5. Those who are, or might become, pregnant during the course of the study
6. Acute Charcot neuropathic osteoarthropathy
7. Those who have skin conditions which may affect healing (e.g. psoriasis) or are on treatments which may impair wound healing (such as systemic steroids or immunosuppressants)
8. Those judged not to be sufficiently compliant with recommendations concerning the off-loading and the requirements of TranCell dressing changes
9. Those in whom revascularisation or other surgical procedures to the affected limb are likely to be considered during the time course of the study
10. Clinically significant active infection (involving soft tissue or bone)
11. Significant peripheral oedema
12. Ulcers probing to bone, joint or tendon
Date of first enrolment01/10/2002
Date of final enrolment31/03/2005

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Royal Hallamshire Hospital
Sheffield
S10 2JF
United Kingdom

Sponsor information

CellTran Ltd (UK)
Industry

The Innovation Centre
217 Portabello
Sheffield
S1 4DP
United Kingdom

Phone +44 (0)114 2220980
Email info@celltran.co.uk
Website http://www.celltran.co.uk

Funders

Funder type

Charity

Wellcome Trust
Private sector organisation / International organizations
Location
United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/11/2007 Yes No

Editorial Notes

04/02/2015: Plain English summary added.