HM242-Gel vs Comparator

NCT04902651 | Terminated

• 1 other identifier: OPM-G-H-2004
• Study Type: interventional
• Target: 73
• Locations: 2 countries
• Sites: 3

Brief Summary

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.

Conditions

Venous Leg Ulcer

Outcome Measures

Primary Outcomes (1)

• 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.

  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

Study Arms (2)

HM242-Gel

EXPERIMENTAL

Device: HM242-Gel

Intrasite Gel

ACTIVE COMPARATOR

Device: Intrasite Gel

Interventions

HM242-Gel DEVICE

HM242-Gel compared to Intrasite Gel in patients with a venous leg ulcer

HM242-Gel

Intrasite Gel DEVICE

HM242-Gel compared to Intrasite Gel in patients with a venous leg ulcer

Intrasite Gel

Eligibility Criteria

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

You may qualify if:

• Males or females of at least 18 years at the time of enrolment
• 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
• 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
• Patients must be willing to have all dressing changes performed by the wound specialist, with no treatments at home
• 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
• Size of study ulcer ≥ 2cm² and ≤ 100cm² measured using the tracing method.
• Presence of venous leg ulcer for at least 6 weeks, but not longer than 12 months
• Ankle Brachial Pressure Index (ABI) \> 0.75
• 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.

You may not qualify if:

• Patients kept in an institution due to an official or court order
• Patients dependent on the Sponsor, Investigator or Site
• Patients suspected of having SARS-CoV-2 infection or COVID-19 disease
• Study ulcer judged by the Investigator to be caused by a medical condition other than venous insufficiency
• Study ulcer with signs and symptoms of infection, or under suspicion of cancer
• Study ulcer under treatment with topical antimicrobials within past two weeks or systemic antimicrobial treatment within past two weeks
• In the case of heavily exuding ulcers, if in the opinion of Investigator the patient is not suitable for treatment with gel
• More than two venous leg ulcers or more than two chronic wounds
• Dementia stage greater than 3 according to Reisberg
• Known allergies against wound dressings used in the study
• Known chronical skin diseases, dermatoses, or known allergies or other conditions which might trigger dermatitis
• Acute cases of substance use disorders (ICD-10 F1x.1 or F1x.2)
• Buerger's disease
• Participation in Medical Device trials less than 4 weeks ago or participation in Drug trials less than six months ago
• Terminally ill patients

Sponsors & Collaborators

• B. Braun Ltd. Centre of Excellence Infection Control: lead

Study Sites (3)

Kožní ambulance Fialová, s.r.o.

Prague, Praha 6, 16000, Czechia

Location

Viliam Cibik

Pruské, 018 52, Slovakia

Location

Rudolf Suchy

Trenčín, 911 01, Slovakia

Location

MeSH Terms

Conditions

Varicose Ulcer

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2021
• First Posted: May 26, 2021
• Study Start: May 21, 2021
• Primary Completion: January 5, 2022
• Study Completion: February 16, 2022
• Last Updated: July 19, 2022

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

SL (2); CZ (1)