LeucoPatch system for the management of hard-to-heal diabetic foot ulcers in the UK, Denmark, and Sweden: an observer-masked, randomised controlled trial.
Abstract
Background The LeucoPatch device uses bedside centrifugation without additional reagents to generate a disc comprising autologous leucocytes, platelets, and fibrin, which is applied to the surface of the wound. We aimed to test the effectiveness of LeucoPatch on the healing of hard-to-heal foot ulcers in people with diabetes.Methods This was a multicentre, international, observer-masked, randomised controlled trial of people with diabetes and a hard-to-heal foot ulcer done in 32 specialist diabetic foot clinics in three countries (UK, Denmark, and Sweden). After a 4-week run-in period, those with a reduction in ulcer area of less than 50% were randomly allocated (1:1) by computer-generated, web-based randomisation (block sizes of two, four, and six) to either prespecified good standard care alone or care plus weekly application of LeucoPatch. The primary outcome was the proportion of ulcers that healed within 20 weeks assessed in the intention-to-treat population (all participants with post-randomisation data collected), defined as complete epithelialisation (confirmed by an observer who was masked to randomisation group), and remained healed for 4 weeks. This trial is registered with the ISRCTN registry, number 27665670, and ClinicalTrials.gov, number NCT02224742.Findings Between Aug 30, 2013, and May 3, 2017, 269 participants were randomly allocated to receive treatment (137 to receive standard care and 132 to receive LeucoPatch). The mean age was 61·9 years (SD 11·6), 217 (82%) were men, and 222 (83%) had type 2 diabetes. In the LeucoPatch group, 45 (34%) of 132 ulcers healed within 20 weeks versus 29 (22%) of 134 ulcers in the standard care group (odds ratio 1·58, 96% CI 1·04-2·40; p=0·0235) by intention-to-treat analysis. Time to healing was shorter in the LeucoPatch group (p=0·0246) than in the standard care group. No difference in adverse events was seen between the groups. The most common serious adverse event (SAE) was diabetic foot infection (24 events in the LeucoPatch group [24% of all SAEs] and 20 in the standard care group [27% of all SAEs]. There were no device-related adverse events.Interpretation The use of LeucoPatch is associated with significant enhancement of healing of hard-to-heal foot ulcers in people with diabetes.Funding Reapplix ApS.
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Pooled data from 14 randomized clinical trials (1083 patients) showed that nonremovable devices were associated with improved healing compared with removable devices (81.9% vs 66.1%; RR, 1.24; 95% CI, 1.09-1.41).
“Pooled data from 14 randomized clinical trials (1083 patients) showed that nonremovable devices were associated with improved healing compared with removable devices (81.9% vs 66.1%; RR, 1.24; 95% CI, 1.09-1.41;P = .001).58”
From Diabetic Foot Ulcers (2023) · cites this paper as [58]
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Experimental — accuracy not yet measuredAchilles tendon lengthening may reduce risk of ulcer recurrence (RR, 3.4; 95% CI, 1.4-8.2) for plantar forefoot ulcers.
“Achilles tendon lengthening may reduce risk of ulcer recurrence (RR, 3.4; 95% CI, 1.4-8.2[absoluterates not provided]) for plantar forefootulcers.51,58”
From Diabetic Foot Ulcers (2023) · cites this paper as [58]
The Background (p. 6) mentions new ulceration after healing, but does not link recurrence to Achilles tendon lengthening. The Outcomes (p. 10) and Results (p. 13) concern healing with LeucoPatch, not the claimed procedure or RR. Searches for Achilles tendon lengthening, plantar forefoot ulcers, and the stated RR and confidence interval found no supporting passage in our copy. (LLM, conf=0.78)
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- Authors
- Game, F., Jeffcoate, W., Tarnow, L., Jacobsen, J. L., Whitham, D. J., Harrison, E. F., Ellender, S. J., Fitzsimmons, D., Löndahl, M., Dhatariya, K., Chant, H., Spyer, G., Donohoe, M., Uchegbu, E., Whitelaw, D., Nayar, R., Rossing, P., Gottlieb, H., Michelsen, M., Nielsen, A. M., Houlind, K., Sørensen, J., Henneberg, E., Jørgensen, B., Narayanan, K., Kong, M.-F., Tarik, A., Gandhi, R., Hariman, C., Oguntolu, V., Rayman, G., Siddique, H., D'Costa, R., Maguire, D., Aung, T., Holmer, H., Catrina, S.-B., Ogunko, A., Rajbhandari, S., & Russell, D.
- Affiliations
- Derby Hospitals NHS Foundation Trust (GB)
- Nottingham University Hospitals NHS Trust (GB)
- Nordsjællands Hospital (DK)
- University of Copenhagen (DK)
- University of Nottingham (GB)
- Swansea University (GB)
- Lund University (SE)
- Corresponding author
- Game, Frances
- ORCID
- Venue
- The Lancet Diabetes & Endocrinology
- Publisher
- Elsevier BV
- Published
- 2018-11
- Volume
- 6
- Issue
- 11
- Pages
- 870-878
- ISSN
- 2213-8587 (ISSN-L)
- OpenAlex
- W2892143706
- Cited by
- 147
- References
- 23
- Citations by year
- 2026: 12 · 2025: 19 · 2024: 20 · 2023: 24 · 2022: 24 · 2021: 14 · 2020: 19 · 2019: 12 · 2018: 3
- FWCI
- 9.54
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- The Lancet Diabetes & Endocrinology (publishedVersion)
- PubMed (publishedVersion)
- Lund University Publications (Lund University) (submittedVersion)
- Research at the University of Copenhagen (University of Copenhagen) (submittedVersion)
- University of Southern Denmark Research Portal (University of Southern Denmark) (submittedVersion)
- Topics
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetic Foot Ulcer Assessment and Management
- Health Sciences › Medicine › Rehabilitation › Wound Healing and Treatments
- Health Sciences › Medicine › Dermatology › Skin Diseases and Diabetes
- Keywords
- diabetic foot ulcer, chronic wounds, platelets, fibrin, wound healing, type 2 diabetes, wound dressings, re-epithelialization
- MeSH terms
- Blood Platelets, Denmark, Female, Fibrin, United Kingdom, Humans, Leukocytes, Male, Middle Aged, Sweden, Wound Healing, Drug Delivery Systems, Treatment Outcome, Diabetic Foot, Transdermal Patch, Re-Epithelialization
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