Diabetic foot ulcer Infections and Infestations Ulcer
Conditions
Interventions
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
Sponsors
CellTran Ltd (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| No secondary outcome measures | — |
Countries
United Kingdom
Outcome results
None listed