Prospective multicentre single-arm cohort investigation to evaluate the performance and safety of wound spray in the treatment of chronic wounds

• Conditions: L97; Ulcer of lower limb, not elsewhere classified

• Registration Number: DRKS00017197
• Lead Sponsor: ohmann & Rauscher GmbH & Co. KG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-05-15
• Study Completion: 2020-12-01
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 67

Inclusion Criteria

• Male or female patients
• Age = 18 years
• Legal competence
• Investigation indication: leg ulcer
• Wound area is > 4 cm2
• Patients has signed written Informed Consent

Exclusion Criteria

• Age < 18 years
• Illiterate patients
• Involved in another therapeutic trial
• Having undergone in the last two months, a surgical procedure in direct connection with its venous insufficiency
• Having presented in the 3 months preceding inclusion a venous thrombosis
• Planned amputation within next two months
• Malignant wounds/patient
• For which a surgical operation in the region of the wound is planned in the next twelve weeks following inclusion
• Gaiter ulcer (circular ulcer)
• Pronounced sclerosis
• High exuding wounds
• Presence of wound pockets
• Pregnancy or breast feeding
• Not compliant to treatment measures for underlying disease (e.g. compression)

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Wound shift (Wound shift means the change of necrotic/fibrinous tissue after four weeks of treatment assessed clinically by the investigator in %)

Secondary Outcome Measures

Name	Time	Method
Wound shift (% of necrotic, fibrinous, granulated and/or epithelised tissue will be measured technically by evaluation of the photographic documentation with W.H.A.T.), reduction of the wound area under treatment. It will be assessed by planimetry and photographs (evaluation with W.H.A.T) at each visit until V3. Additionally, the percentage of healed wounds, achieved healing rate, change in patients’ pain (measured with pain Visual Analogue Scale (VAS)), changes in patients’ quality of life, tolerance/safety of the wound spray, user satisfaction and duration of treatment as well as usability.