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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00017197

Enrollment

Registered

2019-05-15

Start date

2019-06-26

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

L97

Interventions

Group 1: Treatment with Medolysin® woundspray

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

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

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)

Design outcomes

Primary

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

Secondary

Measure	Time frame
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.	—

Measure

Time frame

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.

—

Countries

Germany

Contacts

Public ContactCornelia Seidlitz

CSG Clinische Studien Gesellschaft mbH

cornelia.seidlitz@csg-germany.com030/2308090

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026