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Interventions - insulin and sulodexide (pilot study)

Author (s)StudyType of interventionSetting and locationNumbers randomisedInclusion criteria/Exclusion criteriaMean age±SD (years) Male/female ratio EthnicityFollow-up periodMain outcome measures
Koblik T et al, 2001PilotRandomised double-blind, placebo-controlled trial
T1: Insulin + sulodexide (600LRV [1 vial] daily for 15 days, followed by 250LSU [1 cap] for 2 months
T2: Insulin + placebo (given is same manner as sulodexide)
Metabolic disease clinic, PolandT1: 12
T2: 6 (planned randomisation was 2:1)
Inclusion: persisting diabetic foot syndrome, monolateral foot ulcers, Type 1 or Type 2.
Excluded: poorly controlled diabetes, genetic hyperlipoproteinemias, systemic diseases and malignancies, gangrene of foot
T1: 52.6±8.5
T2: 57.2 (11.1)

T1: M8, F4
T2: M3, F3

Ethnicity not stated

T1: Type 1 2, Type 2 10
T2: Type 1 2, Type 2 4
10 weeksUlcer healing rate
Results
T1: 92% of foot ulcers healed, mean time to healing 46.4±5.2 days. T283% healed, in 63±8.5 days, 95% CI on difference −36.7, 3.47, p=0.09

From: Appendix 17, Sulodexide

Cover of Clinical Guidelines for Type 2 Diabetes
Clinical Guidelines for Type 2 Diabetes: Prevention and Management of Foot Problems [Internet].
NICE Clinical Guidelines, No. 10.
School of Health and Related Research (ScHARR), University of Sheffield.
Sheffield (UK): University of Sheffield; 2003.
Copyright © 2003, School of Health and Related Research (ScHARR), University of Sheffield.

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