Topic: Diabetes Research Network
Conditions
Interventions
Leucopatch, topical application of a fibrin/white cell/platelet patch prepared by the Leucopatch device
Study Entry : Registration and One or More Randomisations
Sponsors
Nottingham University Hospitals NHS Trust (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. People aged 18 years and over who have diabetes complicated by one or more ulcers on a foot or both feet below the level of the malleoli, excluding ulcers confined to the interdigital cleft 2. Those with more than one eligible ulcer will have one usually the largest or more clinically significant selected at screening as the index ulcer 3. Eligible ulcers will be hard-to-heal, meaning that the cross-sectional area will decrease by less than 50 % during a four week run-in period 4. HbA1c =108 mmol/mol at screening 5. The cross-sectional area of the index ulcer will be between =50 and =1000 mm2 at the end of the 4 week run-in period 6. At randomisation, the index ulcer will be clinically non-infected according to IDSA criteria 7. Either the ankle-brachial index (ABPI) in the affected limb will be between 0.50 and 1.40 or the dorsalis pedis pulse and/or tibialis posterior pulse will be palpable 8. Participants will have the capacity to understand study procedures, and will be able to provided written informed consent Target Gender: Male & Female ; Lower Age Limit 18 years
Exclusion criteria
Exclusion criteria: Current exclusion criteria as of 05/01/2017: 1. Haemoglobin concentration <105 g/L or 6.5 mmol/L at screening 2. Presence of sickle-cell anaemia, haemophilia, thrombocytopenia (<100x109/L) or other clinically significant blood dyscrasia 3. Known potential infectivity of blood products, including known HIV and hepatitis 4. Dialysis or an estimated GFR (based on cystatine C or serum creatinine) <20 ml/min/1.73m2 5. Increase in cross-sectional area of the index ulcer by =25% during the 4 week run-in period, or is either smaller than 50 mm2 or larger than 1000 mm2 at the end of that time 6. Clinical signs of infection of the index ulcer or reason to suspect that infection is present at randomisation. 7. Revascularisation procedure in the affected limb planned, or undertaken within the 4 weeks prior to screening 8. Current treatment with cytotoxic drugs or with systemically administered glucocorticoids or other immunosuppressants. 9. Treatment of foot ulcers with growth factors, stem cells or equivalent preparation within the 8 weeks prior to screening 10. The need for continued use of negative pressure wound therapy 11. Likely inability to comply with the need for weekly visits because of planned activity 12. Participation in another interventional clinical foot ulcer-healing trial within the 4 weeks prior to screening 13. Prior randomisation in this trial 14. Judgement by the investigator that the patient does not have the capacity to understand the study procedures or provide written informed consent Previous exclusion criteria: 1. Haemoglobin concentration <105 g/L or 6.5 mmol/L at screening 2. Presence of sickle-cell anaemia, haemophilia, thrombocytopenia (<100x109/L) or other clinically significant blood dyscrasia 3. Known potential infectivity of blood products, including known HIV and hepatitis 4. Dialysis or an estimated GFR (based on cystatine C or serum creatinine) <20 ml/min/1.73m2 5. Increase in cross-sectional area of the index ulcer by =25% during the 4 week run-in period, or is either smaller than 50 mm2 or larger than 1000 mm2 at the end of that time 6. Revascularisation procedure in the affected limb planned, or undertaken within the 4 weeks prior to screening 7. Current treatment with cytotoxic drugs or with systemically administered glucocorticoids 8. Treatment of foot ulcers with growth factors, stem cells or equivalent preparation within the 8 weeks prior to screening 9. Likely inability to comply with the need for weekly visits because of planned activity 10. Participation in another interventional clinical foot ulcer-healing trial within the 4 weeks prior to screening 11. Prior enrolment in this trial 12. Judgement by the investigator that the patient does not have the capacity to understand the study procedures or provide written informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Ulcer healing; Timepoint(s): 20 weeks after randomisation | — |
Secondary
| Measure | Time frame |
|---|---|
| Added 05/01/2017: Ulcer-related outcomes: 1. Time (days) to healing in those that heal by 20 weeks 2. The incidence of healing within 12 and 26 weeks 3. Change in ulcer area at 4, 12, 16, 20 and 26 weeks 4. Change in ulcer healing rate between the run-in-period and the first four weeks in the treatment period 5. The incidence of secondary infection 6. Number of days of systemic antibiotic therapy administered for infection of foot ulcer during the 20 weeks from randomisation 7. Durability of wound healing 12 weeks after complete wound healing Patient-related outcomes: 1. The incidence of major (above ankle) amputation affecting the target limb by 12, 20 and 26 weeks 2. The incidence of major amputation affecting the contralateral limb by 26 weeks 3. The incidence of minor (below ankle) amputation affecting the target limb by 12, 20 and 26 weeks 4. The incidence of minor amputation affecting the contralateral limb 5. Quality-of-life measured using SF-12 and EQ-5D at baseline, 12 and 20 weeks 6. Pain measured by VAS 7. Incidence of new anaemia Health economic analysis: 1. Cost effectiveness and cost utility | — |
Countries
Denmark, Sweden, United Kingdom
Outcome results
None listed