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

Not Applicable

Completed

• Conditions: Diabetic foot ulcer; Infections and Infestations; Ulcer

• Registration Number: ISRCTN14871374
• Lead Sponsor: CellTran Ltd (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-07-22
• Last Update Posted: 17 October 2016

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 16

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified