HM242-Gel vs Comparator

A PROSPECTIVE, CONTROLLED, RANDOMIZED, OPEN-LABEL PREMARKET MULTICENTER STUDY OF THE PERFORMANCE OF THE HM242-GEL VS COMPARATOR IN PATIENTS UNDER THE CONDITION OF VENOUS LEG ULCER

The primary objective of the study is to demonstrate that the HM242-Gel performs at least comparably to INTRASITE Gel with regard to wound healing.

Study Overview

Status

Terminated

Conditions

Study Type

Interventional

Enrollment (Actual)

73

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Praha 6
      • Praha, Praha 6, Czechia, 16000
        • Kožní ambulance Fialová, s.r.o.
      • Pruské, Slovakia, 018 52
        • Viliam Cibik
      • Trenčín, Slovakia, 911 01
        • Rudolf Suchy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Males or females of at least 18 years at the time of enrolment
  2. The legal capacity and ability to understand the nature, risks, significance and scope of the clinical trial and to determine his or her will accordingly
  3. Signed form of consent, including the understanding of and willingness by the patient to participate in the clinical study and ability to comply with study procedures and study visit schedule
  4. Patients must be willing to have all dressing changes performed by the wound specialist, with no treatments at home
  5. Presence of at least one venous ulcer of the lower leg extending through the full thickness of the skin but not down to muscle, tendon or bone
  6. Size of study ulcer ≥ 2cm² and ≤ 100cm² measured using the tracing method.
  7. Presence of venous leg ulcer for at least 6 weeks, but not longer than 12 months
  8. Ankle Brachial Pressure Index (ABI) > 0.75
  9. In the case of a female patient of childbearing potential, willingness to use highly effective methods of contraception (failure rate of < 1% when used consistently and correctly);acceptable contraceptive measures in this trial are: combined pill and progestin-only pill, contraceptive patch, ring or injection, Etonogestrel implant, intrauterine device (IUD) (copper and Levonogestrel), male sterilization (vasectomy), female sterilization (abdominal, laparoscopic, hysteroscopic), or sexual abstinence.

Exclusion Criteria:

  1. Patients kept in an institution due to an official or court order
  2. Patients dependent on the Sponsor, Investigator or Site
  3. Patients suspected of having SARS-CoV-2 infection or COVID-19 disease
  4. Study ulcer judged by the Investigator to be caused by a medical condition other than venous insufficiency
  5. Study ulcer with signs and symptoms of infection, or under suspicion of cancer
  6. Study ulcer under treatment with topical antimicrobials within past two weeks or systemic antimicrobial treatment within past two weeks
  7. In the case of heavily exuding ulcers, if in the opinion of Investigator the patient is not suitable for treatment with gel
  8. More than two venous leg ulcers or more than two chronic wounds
  9. Dementia stage greater than 3 according to Reisberg
  10. Known allergies against wound dressings used in the study
  11. Known chronical skin diseases, dermatoses, or known allergies or other conditions which might trigger dermatitis
  12. Acute cases of substance use disorders (ICD-10 F1x.1 or F1x.2)
  13. Buerger's disease
  14. Participation in Medical Device trials less than 4 weeks ago or participation in Drug trials less than six months ago
  15. Terminally ill patients
  16. Patients with poorly managed diabetes mellitus: absence of a glycated hemoglobin test within the last 3 months or a result of HbA1c ≥ 8% not older than 3 months, or a major diabetes-related incident within the past 4 weeks
  17. Ulcers of diabetic origin
  18. Patients under treatment with systemic corticosteroids, immunosuppressant, cytotoxic chemotherapy, or radiotherapy
  19. Presence of one or more medical conditions (other than venous insufficiency and diabetes) as determined by medical history, which:

    • Is known to interfere with the wound healing process (e.g. arteriopathy, vasculitis, rheumatoid arthritis, systemic lupus erythematosus, other auto-immune diseases, cancer, immunodeficiency, severe lymphedema of the leg, thrombophilia)
    • In the opinion of the Investigator, would make the patient an inappropriate candidate for this venous ulcer healing study (e.g. malnutrition, hygiene, obesity)
  20. Pregnant or lactating patients

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: HM242-Gel
HM242-Gel compared to Intrasite Gel in patients with a venous leg ulcer
Active Comparator: Intrasite Gel
HM242-Gel compared to Intrasite Gel in patients with a venous leg ulcer

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The primary objective of the study is to demonstrate that the HM242-Gel performs at least comparably to INTRASITE Gel with regard to wound healing.
Time Frame: 28 days
The primary variable is defined as the relative reduction of the wound area of a patient in percentage 28 days (4 weeks) after baseline. The wound size area is measured on site by the tracing method.
28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 21, 2021

Primary Completion (Actual)

January 5, 2022

Study Completion (Actual)

February 16, 2022

Study Registration Dates

First Submitted

May 21, 2021

First Submitted That Met QC Criteria

May 21, 2021

First Posted (Actual)

May 26, 2021

Study Record Updates

Last Update Posted (Actual)

July 19, 2022

Last Update Submitted That Met QC Criteria

July 15, 2022

Last Verified

May 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • OPM-G-H-2004

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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