Peripheral Neuropathy Trial, Recruiting NCT05588583 Sponsor: Molnlycke Health Care AB Condition: Peripheral Neuropathy
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Peripheral Neuropathy Trial, Recruiting

NCT05588583
Recruiting Not Applicable

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People who have given signed consent to participate, including consent for digital photos of their wound
  • Adults aged 18 years or older
  • People who have been diagnosed with a long-term (chronic), fluid-producing venous leg ulcer (VLU) or diabetic foot ulcer (DFU)
  • People whose wound is producing a moderate to large amount of fluid
  • People with a venous leg ulcer sized between 3 cm² and 30 cm², or a diabetic foot ulcer of at least 1 cm², as measured by the treating clinician
  • For venous leg ulcer patients: a blood flow test result (ABPI) taken within the last 3 months showing a reading above 0.7, or if the reading is above 1.4, an additional toe pressure or blood flow test confirming normal circulation in the lower leg is required (confirm with trial site)
  • For venous leg ulcer patients: willingness to follow compression therapy as part of treatment

Who may not be able to join:

  • People whose wound is infected in a way that requires antibiotic tablets or medicines (taken by mouth or injection) to be started or continued at the time of joining the trial
  • People whose wound goes all the way around a limb or body part (a circumferential wound)
  • People who have a known allergy or sensitivity to the materials used in the wound dressing being studied
  • People who are already taking part in a separate study called the DIPLO NBF study
  • People who are currently using wound filler products in their wound

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 16 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Principal Investigator: Hadar Lev-Tov, MD, MAS, University of Miami

Phone: 734-358-2174

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Not Applicable
Sponsor
Molnlycke Health Care AB
Registry
ClinicalTrials.gov
Start date
31 October 2022
Est. completion
1 March 2024

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Wound progress of the total effect of treatment using Mepilex Up

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 16 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov