Status and phase
Conditions
Treatments
About
A Research Study to evaluate the safety and potential efficacy of ON101 cream for the treatment of venous leg ulcers.The objectives of the study are to determine the safety and to explore the potential efficacy of ON101 cream in patients with venous leg ulcers.
Full description
This is a multi-center, open-label study to investigate the Safety and Potential Efficacy of ON101 Cream in Venous Leg Ulcers (VLU) patients. Subjects with VLU of CEAP C6 (active venous ulcer) or C6R (recurrent active venous ulcer) are to be included in this study. If a subject has more than one ulcer on the leg, the most severe ulcer then the largest ulcer that confirm to meet the eligibility criteria will be selected for study evaluation.
12 eligible subjects will be enrolled and receive ON101 cream treatment. Enrolled subjects will be instructed to apply the study treatment on the selected target ulcer for a maximum of 18 weeks, until the ulcer complete closure (ulcer size of 0) for two consecutive visits that at least 2 weeks apart, or until the subject exit the study prematurely due to any reason. Identical standard of care (SoC) procedure will be performed in both the control and investigational product arms throughout the study period, which including ulcer cleansing, debridement if necessary, and application of a suitable dressing and compression system until complete ulcer closure. Subjects are required to apply compression device at least 8 hours per day throughout the treatment period.
The study consists of three periods, a 2-week Screening/Run-in period, an up-to-18-week Treatment period, and a 1-to-2-week Follow-up period. The Screening/Run-in period is to ensure the subjects' eligibility and their compliance to compression therapy and to exclude subjects who demonstrate substantial healing resulting solely from improved compliance with SoC. The Treatment period is to determine the safety and to explore the potential efficacy of the study product. The Follow-up period is to assess the safety. During the Follow-up period, SoC will be provided to subjects with non-healing or recurrent target ulcer.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Has signed a written informed consent prior to the study procedure
Male or female aged at least 20 years old
Venous outflow/venous capacitance (VO/VC) compatible with venous insufficiency measured at screening visit or within 3 months prior to enrollment
Has adequate vascular perfusion of the affected limb, confirmed by Ankle-Brachial Index (ABI) ≥ 0.8 and ≤ 1.3 measured at screening visit or within 3 months prior to enrollment
The target ulcer have all of the following characteristics:
Considered by the Investigator to be compliant/adhere to the compression device during the 2-week run-in period
If female of child-bearing potential, has a negative pregnancy test on urine at screening and must not be breastfeeding
Able and willing to attend the scheduled visits and comply with the study procedures.
Exclusion criteria
Presence of necrosis, purulence, or sinus tracts that cannot be removed by debridement
With deep vein thrombosis within 4 weeks prior to enrollment
Has endovenous surgery planned or performed within 4 weeks prior to enrollment
Laboratory values at Screening of:
Presence of any clinically significant medical condition(s) in medical history during screening period that, in the opinion of the Investigator, could interfere with ulcer healing, including but not limited to the following:
Has received treatment with immunosuppressive or chemotherapeutic agents, radiotherapy, or systemic corticosteroids within 4 weeks prior to enrollment
Heavy smoker (≥ 20 cigarettes per day)
Use of any investigational drug or therapy within 4 weeks prior to enrollment
A psychiatric condition (e.g., suicidal ideation), current or chronic alcohol or drug abuse problem, determined from the subject's medical history, which in the opinion of the Investigator, may pose a threat to subject compliance
Judged by the Investigator to be not suitable for study participation
Primary purpose
Allocation
Interventional model
Masking
12 participants in 1 patient group
Loading...
Central trial contact
Yu-ting Kuo, MS; Jui-ching Chen, PhD
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal