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A pilot study to evaluate the efficacy of ‘Aesten Inject ® ’ used in treatment of patients with lateral ankle sprain

A prospective, multi-center, comparative, randomized, open label,pilot study to evaluate the efficacy of ‘Aesten Inject ® ’ used in treatment of patients with lateral ankle sprain

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0010078
Enrollment
90
Registered
2024-12-26
Start date
2024-12-30
Completion date
Unknown
Last updated
2025-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Others(Human tissue ) : In the Aesten Inject® injection experimental treatment group, the participants will be positioned in the supine position. An ultrasound probe will be placed on the medial side

Sponsors

Inje University Busan Paik Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Adults aged 19 to 50 years, both male and female 2)Patients within 48 hours of injury with no previous history of the same ankle sprain 3)Patients with Grade II partial tear of the anterior talofibular ligament confirmed by ultrasound 4)Patients willing to participate in the clinical trial, comply with the treatment and procedures, and visit the hospital for all follow-up assessments 5)Patients who have listened to an explanation about the purpose, methods, and potential effects of the clinical trial and voluntarily signed the informed consent form

Exclusion criteria

Exclusion criteria: 1)Patients with a history of injections or physical therapy treatments on the same ankle 2)Patients with serious underlying conditions (e.g., cancer, kidney disease, liver disease, neurological disorders, bleeding disorders, dementia) 3)Patients with motor or sensory impairments in the affected limb due to neurological disorders 4)Pregnant or breastfeeding patients 5)Patients whom the investigator deems unsuitable for participation in the study

Design outcomes

Primary

MeasureTime frame
Active range of motion

Secondary

MeasureTime frame
VAS(Visual Analogue Scale) ;FAOS (Foot and Ankle Outcome Score);all adverse events

Countries

Korea, Republic of

Contacts

Public ContactDae-Yoo Kim

Inje University Busan Paik Hospital

kdyhoho@hanmail.net+82-51-890-6114

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026