Status:
COMPLETED
LeucoPatch in the Management of Hard-to-heal Diabetic Foot Ulcers
Lead Sponsor:
Nottingham University Hospitals NHS Trust
Conditions:
Diabetic Foot Ulcer
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Diabetic foot ulcers are the source of considerable suffering and cost and there are currently no wound care products available that have been demonstrated to improve healing, or that are cost effecti...
Eligibility Criteria
Inclusion
- 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.
- Those with more than one eligible ulcer will have one - usually the largest or more clinically significant - selected at screening as the index ulcer.
- 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.
- The cross-sectional area of the index ulcer will be ≥50 and ≤1000 mm2 at the end of the 4 week run-in period.
- At randomisation, the index ulcer will be clinically non-infected according to IDSA criteria
- 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.
- HbA1c ≤108 mmol/mol at screening
- Participants will have the capacity to understand study procedures, and will be able to provide written informed consent.
Exclusion
- Haemoglobin concentration \<105 g/L or 6.5 mmol/L at screening.
- Presence of sickle-cell anaemia, haemophilia, thrombocytopenia (\<100x109/L) or other clinically significant blood dyscrasia
- Known potential infectivity of blood products, including known HIV and hepatitis
- Dialysis or an estimated GFR (based on cystatine C or serum creatinine) \<20 ml/min/1.73m2
- 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.
- Clinical signs of infection of the index ulcer or reason to suspect that infection is present at randomisation.
- Revascularisation procedure in the affected limb planned, or undertaken within the preceding 4 weeks.
- Current treatment with cytotoxic drugs or with systemically administered glucocorticoids or other immunosuppressants.
- Treatment of foot ulcers with growth factors, stem cells or equivalent preparation within the preceding 8 weeks
- The need for continued use of negative pressure wound therapy
- Likely inability to comply with the need for weekly visits because of planned activity.
- Participation in another interventional clinical foot ulcer-healing trial within last the 4 weeks at the time of screening.
- Prior randomisation in this trial.
- Judgement by the investigator that the patient does not have the capacity to understand the study procedures or provide written informed consent.
Key Trial Info
Start Date :
August 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2018
Estimated Enrollment :
269 Patients enrolled
Trial Details
Trial ID
NCT02224742
Start Date
August 1 2013
End Date
May 1 2018
Last Update
June 25 2018
Active Locations (32)
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1
Steno Diabetes Center
Gentofte Municipality, Denmark
2
Herlev Hospital
Herlev, Denmark
3
Nordsjællands Hospital
Hillerød, Denmark
4
Kolding Sygehus
Kolding, Denmark, 6000