Safety and Tolerability of Single and Multiple Doses of SoftOx Biofilm Eradicator (SBE) in Chronic Leg Wounds
Status:
Completed
Trial end date:
2022-08-19
Target enrollment:
Participant gender:
Summary
Single-centre clinical study investigating the safety and tolerability of randomised,
double-blinded, placebo-controlled ascending single doses of topically applied SoftOx Biofilm
Eradicator (SBE) in patients with chronic leg wounds and of open-label once daily, twice
daily, and thrice daily dosing of topically applied SBE for five days in patients with
chronic leg wounds. The primary objective of the study is to assess the safety and
tolerability of single and multiple doses of topically applied SBE in patients with chronic
leg wounds. A secondary objective of the study is to assess changes in bacterial burden in
the leg wound after treatment with SBE.