Clinical Trials Logo
  1. Home
  2. Venous Leg Ulcer
  3. NCT05608317

A Clinical Investigation to Follow the Progress of Exuding Chronic Venous Leg Ulcers Using a Non-Bordered Foam Dressing

Venous Leg Ulcer Clinical Trial

Official title:
A Prospective, Open, Multi-Center, Interventional, Non-Comparative Clinical Investigation to Follow the Progress of Exuding Venous Leg Ulcers Using a Non-Bordered Foam Dressing

Clinical Trial Summary

The goal of this clinical trial to follow the progress of wounds in those with chronic venous leg ulcers while using a non-bordered foam dressing. The main objective is to follow the progress of these wounds over time from initial visit to each follow-up visit. Participants will be asked to wear the dressing for up to 6 weeks of treatment or until healed, changed at every one-week interval.

Clinical Trial Description

This investigation is designed as a prospective, open, multi-center, interventional, non-comparative investigation with the aim to follow chronic wound progression for 6 weeks according to local standard of care. Wound progress is a summary endpoint of the total effect of treatment using the non-bordered foam dressing as the absorbent dressing and includes the changes in an objectively measured wound area and subjectively evaluated wound condition. The only included indication is Venous Leg Ulcers (VLU). A total of n=20 participants will be recruited at up to 6 centers within the US and Canada. There will be a total of seven (7) visits to the investigation site for participants during the treatment period: baseline, followed by weekly visits up to six (6) weeks post baseline. During visits, evaluations will be performed to assess wound progression and status, wound dressing properties, as well as Subject pain, comfort, and quality of life. Safety will be assessed at all visits. One target wound per participant will be included in this investigation. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05608317
Study type Interventional
Source Molnlycke Health Care AB
Contact Janet Kandrevas, MD, MS
Phone 734-358-2174
Email janet.kandrevas@molnlycke.com
Status Recruiting
Phase N/A
Start date November 8, 2022
Completion date November 30, 2024
View Details
See also
  Status Clinical Trial Phase
Completed NCT03903692 - A Comparative Evaluation of a MPS Dressing and a CMC Dressing on Subjects With Lower Extremity Venous Ulcers N/A
Completed NCT03257254 - Effect of VarIthena on Wound Healing in Venous Leg Ulcers (VLU)
Recruiting NCT03666754 - Early Glue Saphenous Vein Ablation With Compression Versus Compression Alone in the Healing of the Venous Ulcer N/A
Withdrawn NCT02912858 - Intermittent Pneumatic Compression of the Foot vs Geko Plus R-2 Neuromuscular Electrostimulation Device in Venous Leg Ulcer Patients N/A
Completed NCT02482038 - Geko Venous Leg Ulcer Study N/A
Completed NCT02652572 - Safety Study to Examine the Systemic Exposure of Granexin® Gel After Topical Application to Venous Leg Ulcers Phase 1
Unknown status NCT01658618 - Safety Study Providing 12 Months Follow-up From First Exposure to HP802-247 in Subjects With Venous Leg Ulcer N/A
Completed NCT05646121 - Suprasorb® A + Ag in the Treatment of Wounds at Risk of Infection and Infected Wounds
Completed NCT03077165 - Dose-response Relationship Study of S42909 on Leg Ulcer Healing Phase 2
Completed NCT04461132 - The Effect of Manual Lymphatic Drainage N/A
Completed NCT05974982 - Treatment Outcome of Autologous PRP Versus Conventional Therapy Among Patients With Chronic Venous Leg Ulcers Phase 1
Completed NCT04011371 - Cyanoacrylate Closure for Treatment of Venous Leg Ulcers N/A
Not yet recruiting NCT03543007 - Evaluating the Safety and Efficacy of GrafixPL™PRIME for the Treatment of Chronic Venous Leg Ulcers N/A
Completed NCT03286140 - Early Venous Reflux Ablation Ulcer Trial N/A
Recruiting NCT05588583 - A Clinical Investigation to Follow the Progress of Exuding Chronic Wounds Using Mepilex® Up as the Primary Dressing. N/A
Not yet recruiting NCT04613687 - Efficacy and Safety of a New Compression System URGO BD001 in the Treatment of VLU (FREEDOM) N/A
Recruiting NCT05549609 - A Study of XSTEM-VLU in Patients With Difficult-to-heal Venous Leg Ulcers Phase 1/Phase 2
Recruiting NCT05409976 - The GORE® VIAFORT Vascular Stent IVC Study N/A
Not yet recruiting NCT05089890 - Clinical Investigation of Sorbact® Dressings N/A
Not yet recruiting NCT03670329 - Management of Infection Risk in Non-comparative Trial (MINT) N/A