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A prospective, multicenter, open-label, randomized, parallel-controlled, superiority clinical trial on the safety and efficacy of a toenail correction device for noninvasive correction and adjunctive treatment of ingrown toenails and periungual soft tissue inflammation caused by ingrown toenails

A prospective, multicenter, open-label, randomized, parallel-controlled, superiority clinical trial on the safety and efficacy of a toenail correction device for noninvasive correction and adjunctive treatment of ingrown toenails and periungual soft tissue inflammation caused by ingrown toenails

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600125058
Enrollment
Unknown
Registered
2026-05-20
Start date
2026-05-20
Completion date
Unknown
Last updated
2026-05-25

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

Conditions

Ingrown nail and paronychia caused by ingrown nail

Interventions

Control group:Receive conventional conservative treatment, including non-surgical measures such as cotton packing, nail groove catheterization, and separation with tape traction (excluding wire correc
Experimental group:Receive toenail correction device treatment from Hangzhou Yuannang Biotechnology Co., Ltd.

Sponsors

Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
8 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1.Aged 8 to 75 years, any gender; 2.Clinically diagnosed with ingrown toenail and/or paronychia of the nail fold caused by ingrown toenail, with =2 affected toes, planned for non-surgical conservative treatment; 3.The participant or their guardian can understand the study purpose, demonstrates sufficient compliance with the study protocol, and signs the informed consent form.

Exclusion criteria

Exclusion criteria: 1.The affected toe has undergone nail avulsion or other finger (toe) nail surgery within the past 3 months, or the affected toe underwent nail avulsion or other finger (toe) nail surgery =3 months ago but has not yet fully recovered or healed; 2.Concomitant phalangeal (toe bone) fracture; 3.Concomitant systemic infection or uncontrolled local infection at the site to be treated, severe soft tissue injury at the intended treatment site, severe vascular or severe nerve injury, malignant tumor, diagnosed severe mental illness, severe malnutrition, or failure of other important organs; 4.Participation in any other clinical trial that could affect this study within 1 month prior to screening; 5.Other circumstances in which the researcher, considering the interests of the trial participant, believes they should not participate in this clinical trial.

Design outcomes

Primary

MeasureTime frame
Treatment efficacy rate;

Secondary

MeasureTime frame
Symptom score improvement rate;Visual Analog Scale Score;Improvement rate of nail curling severity;Patient satisfaction;

Countries

China

Contacts

Public ContactChao Liu

Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

liuchaozju@zju.edu.cn+86 5718788795

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 30, 2026