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 |
| Protocol serial number | 068906 |
| Sponsor | CellTran Ltd (UK) |
| Funder | Wellcome Trust |
- 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
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
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 |
|---|---|
| s.heller@sheffield.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled single-blind prospective pilot study |
| Secondary study design | Randomised controlled trial |
| 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 |
| Study objectives | 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(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure(s) |
1. Rate of ulcer healing over six and 12 weeks |
| Key secondary outcome measure(s) |
No secondary outcome measures |
| Completion date | 30/09/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 16 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/10/2002 |
| Date of final enrolment | 31/03/2005 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
S10 2JF
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not 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.
