HM242-Solution vs Comparator
Prospective, Controlled, Randomized, Double-blind, Premarket Multi-centre Study on the Performance of HM242-Solution vs Comparator in Patients Under Condition of Venous Leg Ulcer
1 other identifier
interventional
142
1 country
2
Brief Summary
The objectives of this study include investigating the performance of HM242-Solution compared to normal Saline with respect to venous leg ulcer healing. Saline is widely used for venous leg ulcer cleansing and has served as comparator or standard treatment in clinical trials evaluating new cleansing products to prove that it is as good as the standard treatment. Data will also be collected on the patients' quality of life and any adverse events that may arise during the study.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started May 2021
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 21, 2021
CompletedStudy Start
First participant enrolled
May 25, 2021
CompletedFirst Posted
Study publicly available on registry
May 26, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2022
CompletedNovember 22, 2021
November 1, 2021
1.4 years
May 21, 2021
November 19, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
The primary objective of the study is to demonstrate that the HM242-Solution performs at least comparably to Saline regarding 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-Solution
EXPERIMENTALSaline
ACTIVE COMPARATORInterventions
HM242-Solution compared to Saline compared in patients with a venous leg ulcer
Eligibility Criteria
You may qualify if:
- Males or females of at least 18 years at the time of enrolment
- Has the legal capacity and is able 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
- 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
- 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
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Asl Napoli 3 Sud
Gragnano, Napoli, 80054, Italy
Dept. of Clinical and Experimental Medicine University of Pisa
Pisa, Toscany, 56126, Italy
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- 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 25, 2021
Primary Completion
October 1, 2022
Study Completion
December 1, 2022
Last Updated
November 22, 2021
Record last verified: 2021-11
Data Sharing
- IPD Sharing
- Will not share