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Sucrose octasulfate dressing versus control dressing in patients with neuroischaemic diabetic foot ulcers (Explorer): an international, multicentre, double-blind, randomised, controlled trial
Sucrose octasulfate dressing versus control dressing in patients with neuroischaemic diabetic foot ulcers (Explorer): an international, multicentre, double-blind, randomised, controlled trial
- Source :
- Lancet Diabetes and Endocrinology, Lancet Diabetes and Endocrinology, Elsevier, 2018, 6 (3), pp.186-196. ⟨10.1016/S2213-8587(17)30438-2⟩
- Publication Year :
- 2018
- Publisher :
- HAL CCSD, 2018.
-
Abstract
- Summary Background Diabetic foot ulcers are serious and challenging wounds associated with high risk of infection and lower-limb amputation. Ulcers are deemed neuroischaemic if peripheral neuropathy and peripheral artery disease are both present. No satisfactory treatment for neuroischaemic ulcers currently exists, and no evidence supports one particular dressing. We aimed to assess the effect of a sucrose octasulfate dressing versus a control dressing on wound closure in patients with neuroischaemic diabetic foot ulcers. Methods We did a randomised, double-blind clinical trial (Explorer) in 43 hospitals with specialised diabetic foot clinics in France, Spain, Italy, Germany, and the UK. Eligible participants were inpatients or outpatients aged 18 years or older with diabetes and a non-infected neuroischaemic diabetic foot ulcer greater than 1 cm 2 and of grade IC or IIC (as defined by the University of Texas Diabetic Wound Classification system). We excluded patients with a severe illness that might lead to them discontinuing the trial and those who had surgical revascularisation in the month before study entry. We randomly assigned participants (1:1) via a computer-generated randomisation procedure (concealed block size two); stratified by study centre and wound area (1–5 cm 2 and 5–30 cm 2 ), to treatment with either a sucrose octasulfate wound dressing or a control dressing (the same dressing without sucrose octasulfate) for 20 weeks. Both groups otherwise received the same standard of care for a 2-week screening period before randomisation and throughout the 20-week trial. Dressings were applied by nursing staff (or by instructed relatives for some outpatients). Frequencies of dressing changes were decided by the investigator on the basis of the clinical condition of the wound. Patients were assessed 2 weeks after randomisation, then monthly until week 20 or occurrence of wound closure. The primary outcome, assessed by intention-to-treat, was proportion of patients with wound closure at week 20. This trial is registered with ClinicalTrials.gov, number NCT01717183. Findings Between March 21, 2013, and March 31, 2016, we randomly assigned 240 individuals to treatment: 126 to the sucrose octasulfate dressing and 114 to the control dressing. After 20 weeks, wound closure occurred in 60 patients (48%) in the sucrose octasulfate dressing group and 34 patients (30%) in the control dressing group (18 percentage points difference, 95% CI 5–30; adjusted odds ratio 2·60, 95% CI 1·43–4·73; p=0·002). In both groups, the most frequent adverse events were infections of the target wound: 33 wound infections in 25 (20%) patients of 126 in the sucrose octasulfate dressing group and 36 in 32 (28%) patients of 114 in the control dressing group. Minor amputations not affecting the wound site were also reported in one (1%) patient in the sucrose octasulfate dressing group and two (2%) patients in the control dressing group. Three (2%) patients assigned to the sucrose octasulfate dressing and four (4%) assigned to the control dressing died, but none of the deaths were related to treatment, procedure, wound progression, or subsequent to amputation. Interpretation A sucrose octasulfate dressing significantly improved wound closure of neuroischaemic diabetic foot ulcers without affecting safety after 20 weeks of treatment along with standard care. These findings support the use of sucrose octasulfate dressing as a local treatment for neuroischaemic diabetic foot ulcers. Funding Laboratoires Urgo Medical.
- Subjects :
- Male
medicine.medical_specialty
Sucrose
Neuroischaemic diabetic foot ulcers
Endocrinology, Diabetes and Metabolism
medicine.medical_treatment
030209 endocrinology & metabolism
Aged
Anti-Ulcer Agents
Diabetic Foot
Diabetic Neuropathies
Double-Blind Method
Female
Humans
International Agencies
Ischemia
Prognosis
Bandages
Settore MED/13 - Endocrinologia
law.invention
030207 dermatology & venereal diseases
03 medical and health sciences
0302 clinical medicine
Endocrinology
Randomized controlled trial
law
Diabetes mellitus
Internal Medicine
Medicine
Adverse effect
integumentary system
business.industry
Odds ratio
[SDV.MHEP.EM]Life Sciences [q-bio]/Human health and pathology/Endocrinology and metabolism
medicine.disease
Diabetic foot
3. Good health
Surgery
Clinical trial
Diabetic foot ulcer
Amputation
Sucrose octasulfate dressing
business
Subjects
Details
- Language :
- English
- ISSN :
- 22138587 and 22138595
- Database :
- OpenAIRE
- Journal :
- Lancet Diabetes and Endocrinology, Lancet Diabetes and Endocrinology, Elsevier, 2018, 6 (3), pp.186-196. ⟨10.1016/S2213-8587(17)30438-2⟩
- Accession number :
- edsair.doi.dedup.....055e68160e1409d05ccad392d2594ebb
- Full Text :
- https://doi.org/10.1016/S2213-8587(17)30438-2⟩