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Effect of rhGM-CSF on the Healing of Venous Leg Ulcers

NCT04823962 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2022-11-17

No results posted yet for this study

Summary

The objective of this study is to examine whether local administration of the growth factor rhGM-CSF incorporated into a hydrogel, can accelerate wound healing when applied to venous leg ulcers, and whether this is safe.

Conditions

  • Venous Leg Ulcer

Interventions

DRUG

rhGM-CSF + hydrogel

The active substance: molgramostim (rhGM-CSF)

DRUG

Placebo hydrogel

Placebo hydrogel

OTHER

Standard care

Compression therapy and neutral dressings

Sponsors & Collaborators

  • Reponex Pharmaceuticals A/S

    lead INDUSTRY

Principal Investigators

  • Ewa A Burian, MD · Department of Dermatology and Copenhagen Wound Healing Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-11
Primary Completion
2023-12-30
Completion
2023-12-30

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04823962 on ClinicalTrials.gov