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 measure
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 (if study stopped)
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
Funders
Funder type
Charity
Funder name
Wellcome Trust
Alternative name(s)
Wellcome
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
Basic results (scientific)
Publication list
2007 results in: http://www.ncbi.nlm.nih.gov/pubmed/18034628
Publication citations
-
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.