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Adding topical pale sulfonated shale oil to compression therapy and moist wound care reduced venous leg ulcer size but had no effect on complete wound healing after 20 weeks

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Q Does topical application of pale sulfonated shale oil (PSSO) in addition to usual care with compression therapy and standard moist wound care improve healing of venous leg ulcers?

METHODS

Embedded ImageDesign:

randomised controlled trial.

Embedded ImageAllocation:

{concealed}.*

Embedded ImageBlinding:

blinded {patients, healthcare providers, data collectors, and outcome assessors}.*

Embedded ImageFollow up period:

to the end of the 20 week treatment period.

Embedded ImageSetting:

13 outpatient wound clinics in Germany and Slovakia.

Embedded ImagePatients:

119 patients >18 years of age (mean age 69 y, 67% women) who had leg ulcers ⩾3 cm2 caused by chronic venous insufficiency. Exclusion criteria were severe cardiac, respiratory, gastrointestinal, liver, or renal disease; malignancy; signs of wound infection; and pregnancy or lactation.

Embedded ImageIntervention:

10% Leukichtan PSSO gel (Ichthyol-Gesellschaft, Germany) (n = 62) or placebo gel (n = 57). Both gels were applied daily …

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