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'Proof of concept study of the apllication of Active Chlorine in patients Treated for Chronic Leg Ulcera to speed up reepithelialisation' (ACTCU)

Conditions
legulcer
10014982
Registration Number
NL-OMON51522
Lead Sponsor
Medisch Centrum Leeuwarden
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Pending
Sex
Not specified
Target Recruitment
10
Inclusion Criteria

leg ulcus consisting over 6 weeks other than exclusivly arterial ulcers

Exclusion Criteria

• Age younger than 18 years
• Suffering from somatic or psychiatric disease which makes it impossible to
come to our outpatient clinic
• Suffering from complicating diseases which also interfere with wound healing

Study & Design

Study Type
Observational non invasive
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<p>What is the effect in reepithelization of chronic ulcers using hypochlorous<br /><br>acid solution during 6 weeks.<br /><br></p><br>
Secondary Outcome Measures
NameTimeMethod
<p>The amount of patients with a >50% reepithelialisation at week 6.<br /><br>• The change in reepithelialisation measured at all visits from baseline till<br /><br>week 6.<br /><br>• The reduction in VAS pain score measured at all visits from baseline till<br /><br>week 6.<br /><br>• The change in pain score measured at all visits from baseline till week 6. </p><br>
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