Condition category
Infections and Infestations
Date applied
22/07/2005
Date assigned
22/07/2005
Last edited
04/02/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

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

Trial website

Contact information

Type

Scientific

Primary contact

Dr Simon Heller

ORCID ID

Contact details

Academic Unit of Diabetes
Endocrinology and Metabolism
M Floor
Royal Hallamshire Hospital
Glossop Road
Sheffield
S10 2JF
United Kingdom
+44 (0)114 271 2162
s.heller@sheffield.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

068906

Study information

Scientific title

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

Acronym

Study hypothesis

This 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

Not provided at time of registration

Study design

Randomised controlled single-blind prospective pilot study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Diabetic foot ulcer

Intervention

This 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 type

Other

Phase

Not Specified

Drug names

Primary outcome measures

1. 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 measures

No secondary outcome measures

Overall trial start date

01/10/2002

Overall trial end date

30/09/2005

Reason abandoned

Eligibility

Participant inclusion criteria

1. 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

16

Participant exclusion criteria

1. 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

Recruitment start date

01/10/2002

Recruitment end date

31/03/2005

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Royal Hallamshire Hospital
Sheffield
S10 2JF
United Kingdom

Sponsor information

Organisation

CellTran Ltd (UK)

Sponsor details

The Innovation Centre
217 Portabello
Sheffield
S1 4DP
United Kingdom
+44 (0)114 2220980
info@celltran.co.uk

Sponsor type

Industry

Website

http://www.celltran.co.uk

Funders

Funder type

Charity

Funder name

Wellcome Trust

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

international

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2007 results in: http://www.ncbi.nlm.nih.gov/pubmed/18034628

Publication citations

  1. Results

    Moustafa M, Bullock AJ, Creagh FM, Heller S, Jeffcoate W, Game F, Amery C, Tesfaye S, Ince Z, Haddow DB, MacNeil S, Randomized, controlled, single-blind study on use of autologous keratinocytes on a transfer dressing to treat nonhealing diabetic ulcers., Regen Med, 2007, 2, 6, 887-902, doi: 10.2217/17460751.2.6.887.

Additional files

Editorial Notes

04/02/2015: Plain English summary added.