A Single Arm Clinical Study Evaluating the Safety, Tolerability, and Efficacy of Multiple Intravenous Administration of TP03HN106 in Patients With Critical Limb Ischemia
NCT Number: NCT06482892
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Critical Limb Ischemia
Interventions: DRUG: TP03HN106
Sponsor: Talengen Institute of Life Sciences, Shenzhen, P.R. China.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 15
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-10
Completion Date: 2024-12-10

Summary:
Critical limb ischemia (CLI) is the most severe ischemic stage in peripheral arterial disease (PAD) of the lower limbs, characterized by decreased walking ability, resting pain (lasting for more than 2 weeks), ulcers, and gangrene, which seriously affect the quality of life of patients. Some patients may even face amputation or death. Thrombosis is an important pathological feature of CLI. TP03HN106 can promote thrombolysis, thus having a therapeutic effect on CLI.

Primary Outcome Measures: VAS score, Changes in VAS scores of subjects compared to baseline during administration of day 6, day 14, day 21, day 34, day 49, and day 62.

VAS is a scale used to measure the intensity of resting pain in subjects. It consists of a 100 mm horizontal line, with a 0 mm point corresponding to the patient's asymptomatic state and a 100mm point representing the most severe symptom state. The subject indicates their current symptom status by drawing a marker on the horizontal line, Baseline, day 6, day 14, day 21, day 34, day 49, and day 62|Ulcer area, Changes in ulcer area of subjects (applicable to patients with ulcers) compared to baseline during administration of day 6, day 14, day 21, day 34, day 49, and day 62., Baseline, day 6, day 14, day 21, day 34, day 49, and day 62.
Secondary Outcome Measures: Ankle brachial index, ABI, Changes in ABI of subjects (applicable to patients with ulcers) compared to baseline during administration of day 6, day 21, day 34, day 49, and day 62 ABI:The ratio of ankle artery systolic pressure to ipsilateral brachial artery systolic pressure, Baseline, day 6, day 21, day 34, day 49, and day 62|TcPO2, Changes in TcPO2 of subjects (applicable to patients with ulcers) compared to baseline during administration of day 6, day 21, day 34, day 49, and day 62 TcPO2: transcutaneous oxygen partial pressure, Baseline, day 6, day 21, day 34, day 49, and day 62|TBI, Changes in TBI of subjects compared to baseline during administration of day 6, day 21, day 34, day 49, and day 62 TBI: The ratio of toe artery systolic pressure to ipsilateral brachial artery systolic pressure, Baseline, day 6, day 21, day 34, day 49, and day 62|The ratio of subjects with unobstructed blood vessels, Use lower limb arterial ultrasound, lower limb computed tomography angiography (CTA), or digital subtraction angiography (DSA) to detect the superficial femoral artery, popliteal artery, anterior tibial artery, posterior tibial artery, and fibular artery. For embolic vessels, the degree of stenosis needs to be measured. The same subject uses the same examination method before and after treatment., Baseline, day 6, day 21, day 34, day 49, and day 62|Rutherford grading, Changes in Rutherford grading of subjects compared to baseline during administration of day 6, day 21, day 34, day 49, and day 62, Baseline, day 6, day 21, day 34, day 49, and day 62
Other Outcome Measures: Coagulation function indicators, Changes in coagulation function of subjects compared to baseline during administration of day 6, day 21, day 34, day 49, and day 62, Baseline, day 6, day 21, day 34, day 49, and day 62|Fibrinogen degradation products (FDP), Changes in FDP of subjects compared to baseline during administration of day 6, day 21, day 34, day 49, and day 62, Baseline, day 6, day 21, day 34, day 49, and day 62|Thrombosis 4 items, Changes in thrombosis 4 items of subjects compared to baseline during administration of day 6, day 21, day 34, day 49, and day 62, Baseline, day 6, day 21, day 34, day 49, and day 62