Phase 2 N=124 Randomized Double-blind Treatment

CSTC1 for Diabetic Foot Ulcers Phase II Study

Diabetic Foot Ulcer · Diabetes Mellitus · Wounds

Bottom Line

View on ClinicalTrials.gov: NCT01813305 ↗

Enrolled (actual)

124

Serious AEs

18.6%

Results posted

Apr 2022

Primary outcome: Primary: Number of Participants With Complete Ulcer Closure During the Treatment Period — 32; 4 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: CSTC1 (Drug); CSTC1 Matched vehicle (Drug)
Age: Adult, Older Adult · 20+ yrs
Sex: All
Sponsor: Charsire Biotechnology Corp.
Primary completion: Jan 2020

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Complete Ulcer Closure During the Treatment Period	32; 4	—
SECONDARY The Ulcer Closure Time	87; 92	—
SECONDARY The Accumulated Participant Counts With Complete Ulcer Closure	0; 0; 0; 0; 0; 0	—
SECONDARY Percentage Change in Ulcer Size for Each Post-treatment Visit	-15.2; -16.3; -28.3; -21.7; -36.3; -29.1	—

Summary

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

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 12%), anemia (hemoglobin 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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01813305). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.