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

NCT04823962 | Unknown Phase 2

• 1 other identifier: Repogel-01
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Proportion of patients reaching a 40% ulcer area reduction, or more, 4 weeks after initiation of the study drug treatment/placebo

  Ulcer size (area in cm2) will be assessed on the randomization day (Day 0; initiation of the study drug treatment/placebo) and at the end of the study drug/placebo treatment (D28+1)

  4 weeks after initiation of the study drug treatment/placebo

Secondary Outcomes (6)

• Absolute change of the ulcer area

  4 and 8 weeks after randomization

• Percentage change of the ulcer area

  4 and 8 weeks after randomization

• Complete ulcer healing

  4 and 8 weeks after randomization

• Time to complete ulcer healing

  Through study completion (8 weeks)

• Clinical improvement of the wound healing process

  4 and 8 weeks after randomization

Other Outcomes (3)

• Exploratory measurement: Changes in the levels of cytokines and growth factors in the wound fluid

  Wound fluid is collected at three time points: Before initiation of the study drug/placebo (Day 0), after two weeks of treatment (Day 14) and at the end of the treatment period (Day 28).

• Exploratory measurement: Wound status

  Throughout the trial (8 weeks)

• Exploratory measurement: Changes in the microbiome (number of viable bacteria)

  Before initiation of study drug and after two weeks of treatment

Study Arms (2)

GM-CSF

EXPERIMENTAL

rhGM-CSF (molgramostim) + hydrogel

Drug: rhGM-CSF + hydrogel; Other: Standard care

Placebo

PLACEBO COMPARATOR

Hydrogel

Drug: Placebo hydrogel; Other: Standard care

Interventions

rhGM-CSF + hydrogel DRUG

The active substance: molgramostim (rhGM-CSF)

Also known as: Repogel, Molgramostim

GM-CSF

Placebo hydrogel DRUG

Placebo hydrogel

Placebo

Standard care OTHER

Compression therapy and neutral dressings

GM-CSF; Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women aged aged 18 years or older
• Patients with at least one difficult-to-heal venous leg ulcer on standard care (diagnosed by clinical evaluation) localized between the knee and ankle, including the perimalleolar area.
• Venous insufficiency confirmed by a venous Doppler/duplex ultrasound scan. A previous scan before randomization can be used. If there is no previous adequate scanning, a new scanning has to be performed before randomization.
• Ulcer size 2-75 cm2 at randomization day (D0), the upper limit being defined as the largest ulcer in size that fits the area selection criteria
• Ulcer duration ≥2 months and ≤3 years
• Negative p-HCG for women of childbearing potential
• Patient able to understand Danish
• Patient able to comply with the protocol
• Patient fully informed about the study and having given written informed consent

You may not qualify if:

• Characteristics of the index ulcer:
• Exposed bone, tendon, ligament, cartilage, joint or muscle
• Cellulitis or clinical ulcer infection at the screening day D-4, or the day of randomization, D0.
• Ulcers adjacent to the index ulcer that could interfere with the index ulcer, as judged by investigator
• Patients that are unsuitable for the compression therapy used in the study
• Known allergy towards GM-CSF, excipients or any other substances or remedies used in the trial.
• Vascularization: Ankle-brachial index ≤0.7
• Active or history of following diseases:
• Cancer (past history of well-treated cancer is however accepted after a control period of more than two years).
• Following autoimmune diseases: rheumatoid arthritis, autoimmune thrombocytopenia, thyroiditis, psoriasis, nephritis or multiple sclerosis.
• Lower extremity deep venous thrombosis within the last 3 months
• Any of following active diseases:
• Serious heart disease, including unstable angina pectoris, a major cardiac event such as myocardial infarction, congestive heart failure NYHA class III-IV within 3 months before the study
• Neutrophilic dermatoses (e.g. pyoderma gangrenosum and Sweet's syndrome)
• Severe renal-, hepatic or pulmonary insufficiency or severely dysregulated diabetes, as judged by investigator

Sponsors & Collaborators

• Reponex Pharmaceuticals A/S: lead

Study Sites (1)

Department of Dermatology and Copenhagen Wound Healing Center, Bispebjerg Hospital

Copenhagen, Denmark

Location

MeSH Terms

Conditions

Varicose Ulcer

Interventions

regramostim; Hydrogels; molgramostim; Standard of Care

Condition Hierarchy (Ancestors)

Varicose Veins; Vascular Diseases; Cardiovascular Diseases; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Gels; Colloids; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Ewa A Burian, MD

  Department of Dermatology and Copenhagen Wound Healing Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prinicipal Investigator, MD

Model Details: A randomized, placebo-controlled and double-blind, phase II clinical trial

Study Record Dates

• First Submitted: March 6, 2021
• First Posted: April 1, 2021
• Study Start: March 11, 2021
• Primary Completion: December 30, 2023
• Study Completion: December 30, 2023
• Last Updated: November 17, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)