Clinical trial NCT01813305: CSTC1 for Diabetic Foot Ulcers Phase II Study
Official title: A Randomized,Double-Blind,Vehicle-controlled,Parallel,Phase II Study to Evaluate Efficacy and Safety of CSTC1 in Patient With Diabetic Foot Ulcers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetic Foot Ulcer
Diabetes Mellitus
Wounds
Keywords: Diabetic Foot Ulcer
Diabetes Mellitus
Debridement
Standard of Care
wounds
Lead sponsor: Charsire Biotechnology Corp.
Sponsor class: INDUSTRY
Collaborators: name: ASKLEP Inc.
First posted: 2013-03-18
Enrollment: 124
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this study is to evaluate the efficacy and safety of CSTC1 in patient with diabetic foot ulcers.

Detailed description: This study was designed as a randomized, double-blind, vehicle-controlled, multiple-center, and parallel trial to evaluate the efficacy and safety of CSTC1 in patients with diabetic foot ulcers (DFU). In each study site, eligible patients were randomized in a 4:1 ratio to receive either one of the topical applications of CSTC1 or CSTC1 matched vehicle, topical application on target diabetic foot ulcer (DFU), 2 times daily.

The treatment duration for each subject was 12 weeks or up to confirmed complete ulcer closure, whichever comes first. That was, subjects would receive treatment for at most 12 weeks, which consists of 8 visits located at weeks 1, 2, 3, 4, 6, 8, 10, and 12. Subjects who achieved confirmed complete ulcer closure during the treatment period would be arranged for a 12 week post-treatment follow-up. Subjects failed to achieve complete ulcer closure at week-12 visit would be arranged for 4 weeks of safety follow-up. If confirmation of complete ulcer closure was reached at a week-14 visit, the subject would continue the post-treatment follow-up visit until week-24 visit. Otherwise, the subject would be arranged for safety follow-up until week-16 visit.

Eligibility criteria: Inclusion Criteria:

* With either gender aged at least 20 years old;
* With a diabetic ulcer (which is defined as the target ulcer) on the foot and not healing for at least 2 weeks;
* The target ulcer is classified as grade 1 or 2 ulcer according to modified Wagner system;
* The target ulcer should show "infection control" at investigator's discretion;
* Subject should be free of any necrosis or infection in soft and bone tissue;
* Subject has signed the written informed consent form

Exclusion Criteria:

* With active osteomyelitis;
* With target ulcer size decreased by at least 50% after at least 2 weeks of standard-of-care-only period or any other recorded regular therapy before Randomization visit;
* With poor nutritional status (albumin \< 3g/dl), poor diabetic control (HbA1c \> 12%), anemia (hemoglobin\<10 g/dL), a leukocyte counts \< 1,000/mm3, abnormal liver function (AST, ALT\>3 x upper limit of normal range);
* Requiring treatment with corticosteroids, immunosuppressive or chemotherapeutic agents;
* Presence of necrosis, purulence or sinus tracts that cannot be removed by debridement;
* Receiving revascularization surgery performed \<8 weeks before entry in the study;
* With known or suspected hypersensitivity to any ingredients of study product and vehicle;
* With coronary heart disease with myocardial infarction, coronary artery bypass graft (CABG), or percutaneous transluminal coronary angioplasty (PTCA) within 3 months prior to study;
* Pregnant or lactating or premenopausal with childbearing potential but not taking reliable contraceptive method(s) during the study period;
* Enrollment in any investigational drug trial within 4 weeks before entering this study;
* With any uncontrolled illness judged by the investigator that entering the trial may be detrimental to the subject.

Primary outcomes:
measure: Number of Participants With Complete Ulcer Closure During the Treatment Period
timeFrame: Baseline to 14 weeks
Secondary outcomes:
measure: The Ulcer Closure Time
timeFrame: 24 weeks
measure: The Accumulated Participant Counts With Complete Ulcer Closure
timeFrame: 24 weeks
measure: Percentage Change in Ulcer Size for Each Post-treatment Visit
timeFrame: baseline and 24 weeks
Other outcomes:
measure: Number of Participants With Adverse Events
timeFrame: 24 weeks
measure: Number of Participants With Physical Abnormality Finding at the Visits
timeFrame: 24 weeks
measure: Number of Participants With Relieved, Unchanged, or Worsen Values in Laboratory Test at Week 12 Compared to Baseline
timeFrame: baseline and 12 weeks
measure: Blood Pressure Change From Baseline to Week 24
timeFrame: baseline and 24 weeks
measure: Pulse Rate Change From Baseline to Week 24
timeFrame: baseline and 24 weeks
measure: Body Temperature Change From Baseline to Week 24
timeFrame: baseline and 24 weeks
measure: Respiratory Rate Change From Baseline to Week 24
timeFrame: baseline and 24 weeks
Locations:
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University Chung-Ho Memorial Hospital
Study officials:
affiliation: Kaohsiung Medical University Chung-Ho Memorial Hospital
name: Su-Shin Lee, MD
role: PRINCIPAL_INVESTIGATOR
References: