LeucoPatch in the Management of Hard-to-heal Diabetic Foot Ulcers

Diabetic Foot Ulcer Clinical Trial

Official title:

LeucoPatch in the Management of Hard-to-heal Diabetic Foot Ulcers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02224742
• Other study ID #: 12EN005
• Secondary ID: ISRCTN27665670
• Status: Completed
• Phase: Phase 4
• Start date: August 2013
• Est. completion date: May 2018

Study information

• Verified date: June 2018
• Source: Nottingham University Hospitals NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 effective. There have however been a small number of studies which have examined the use of platelets or fluid derived from platelets, either from the patient's own blood or from blood bank products. These have suggested some promise, but have suffered from technical difficulties in making a suitable wound care product or the volume of blood required to derive the product. It is thought that the reason why they may work is that growth factors released by the platelets may stimulate the wound to heal.

This study will be a formal, randomised controlled trial to assess a new device for creating a wound care product which is a plug or patch comprising fibrin, white cells and platelets derived from 18 mls of the patients own blood. The application of this fibrin/white cell/platelet patch to the patients wound on a weekly basis will be compared with usual best care in patients with hard to heal Diabetic Foot Ulcers in a secondary care setting in 25 centres in the United Kingdom, Denmark and Sweden.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 269
• Est. completion date: May 2018
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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 Criteria:

• 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.

Related Conditions & MeSH terms

• Diabetic Foot
• Diabetic Foot Ulcer
• Foot Ulcer
• Ulcer

Intervention

Device:
• LeucoPatch
LeucoPatch® is prepared by centrifuging one or more 18mL aliquots of the participant's venous blood in the LeucoPatch device and bench-top centrifuge. The centrifugation yields a tough layer of fibrin, with viable white cells and platelets, and this is applied directly to the wound surface using sterile forceps. The wound is then covered with an inert primary dressing, secondary protective dressing and the ulcerated area protected with appropriate off-loading. The patch is prepared and applied each week for up to 20 weeks or until the wound is judged healed.

Other:
• Usual care
Usual wound care provided in a multidisciplinary foot care clinic , in accordance with international guidelines. Components of usual wound care include: Formal assessment of ulcer and surrounding skin Provision of any necessary off-loading Debridement (i) sharp, (ii) other as appropriate (but excluding the use of larvae) Appropriate dressing products Appropriate antibiotic therapy Nutrition and self care Optimal glycaemic control Revascularisation if deemed clinically necessary Continued close observation

Locations

Country	Name	City	State
Denmark	Steno Diabetes Center	Gentofte
Denmark	Herlev Hospital	Herlev
Denmark	Nordsjællands Hospital	Hillerød
Denmark	Bispebjerg Hospital	Kobenhavn NV
Denmark	Kolding Sygehus	Kolding
Denmark	Odense University Hospital	Odense
Denmark	Viborg Sårcenter	Viborg
Sweden	Centralsjukhuset Kristianstad	Kristianstad
Sweden	Skåne University Hospital	Lund
Sweden	Karolinska University Hospital	Solna
United Kingdom	Barnsley Hospital NHS Foundation Trust	Barnsley
United Kingdom	Bradford Teaching Hospitals NHS Foundation Trust	Bradford
United Kingdom	Lancashire Teaching Hospitals NHS Foundation Trust	Chorley
United Kingdom	Dartford and Gravesham NHS Trust	Dartford
United Kingdom	Derby Hospitals NHS Foundation Trust	Derby
United Kingdom	The Dudley Group NHS Foundation Trust	Dudley
United Kingdom	Royal Devon & Exeter NHS Foundation Trust	Exeter
United Kingdom	Gateshead Health NHS Foundation Trust	Gateshead
United Kingdom	Harrogate and District NHS Foundation Trust	Harrogate
United Kingdom	The Ipswich Hospital NHS Trust	Ipswich	Suffolk
United Kingdom	The Leeds Teaching Hospitals NHS Trust	Leeds
United Kingdom	University Hospitals of Leicester NHSTrust	Leicester
United Kingdom	United Lincolnshire Hospitals NHS Trust	Lincoln
United Kingdom	Norwich and Norwich University Hospitals NHS Foundation Trust	Norwich
United Kingdom	Nottingham University Hospitals NHS Trust	Nottingham
United Kingdom	The Mid Yorkshire Hospitals NHS Trust	Pontefract	West Yorkshire
United Kingdom	Royal Berkshire NHS Foundation Trust	Reading
United Kingdom	Sheffield Teaching Hospitals NHS Foundation Trust	Sheffield
United Kingdom	City Hospitals Sunderland NHS Foundation Trust	Sunderland
United Kingdom	South Devon Healthcare NHS Foundation Trust	Torquay	Devon
United Kingdom	Royal Cornwall Hospitals NHS Trust	Truro	Cornwall
United Kingdom	Royal Wolverhampton Hospitals NHS Trust	Wolverhampton

Sponsors (1)

Lead Sponsor	Collaborator
Nottingham University Hospitals NHS Trust

Countries where clinical trial is conducted

Denmark,  Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Healing	Healing will be defined as complete epithelialisation without discharge that is maintained for 4 weeks and is confirmed by an observer blind to randomisation group.	Within 20 weeks of randomisation