Randomized controlled clinical study to assess the clinical efficacy of the 3M* Coban* 2 Layer Compression System compared to a short-stretch compression bandage in the treatment fo venous leg ulcers

Randomized controlled clinical study to assess the clinical efficacy of the 3M* Coban* 2 Layer Compression System compared to a short-stretch compression bandage in the treatment fo venous leg ulcers - Compression therapy of venous leg ulcer

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON31099

Enrollment

Registered

2007-10-19

Start date

2008-02-06

Completion date

Unknown

Last updated

2024-11-11

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

Conditions

treatment of venous leg ulcer

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Subjects having a venous leg ulcer (stage C6 according CEAP classification, venous pathology proved by the presence of reflux (Pr)), which is at least 1 cm in any dimension but not larger than 10 cm in any dimension and has at least 5 cm distance to additional ulcers.

Exclusion criteria

Exclusion criteria: Subjects with an ABPI

Design outcomes

Primary

Measure	Time frame
Primary endpoint is the complete study ulcer-healing rate (defined as number complete study ulcer healed divided by the total number of subjects) the treatment period of up to 12 weeks. The wound healing status will be assessed clinically and documented during every visit for bandage change. Wound status and ulcer size will be recorded and photo documented. Final assessment of ulcer healing will be blinded. Complete ulcer healing is defined as complete re-epithelialization of the study ulcer.	—

Measure

Time frame

Primary endpoint is the complete study ulcer-healing rate (defined as number complete study ulcer healed divided by the total number of subjects) the treatment period of up to 12 weeks. The wound healing status will be assessed clinically and documented during every visit for bandage change. Wound status and ulcer size will be recorded and photo documented. Final assessment of ulcer healing will be blinded. Complete ulcer healing is defined as complete re-epithelialization of the study ulcer.

—

Secondary

Measure	Time frame
Secondary endpoints are the health related quality of life, as assessed using the Cardiff Wound Impact Schedule (CWIS) at enrollment and end of treatment, and a treatment cost calculation, based on material costs and cost for nursing and doctor visits. Additional endpoints are time to complete ulcer closure, bandage wear time, reduction in ulcer size and safety (adverse event documentation).	—

Countries

Netherlands

Outcome results