Skip to content

A prospective randomized controlled study of flexor tenotomy for offloading treatment of diabetic foot

A prospective randomized controlled study of flexor tenotomy for offloading treatment of diabetic foot

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600126071
Enrollment
Unknown
Registered
2026-06-03
Start date
2026-06-03
Completion date
Unknown
Last updated
2026-06-08

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

Conditions

diabetic foot ulcer

Interventions

experimental group:selective toe flexor tenotomy
Control group:Standard treatment protocol for diabetic foot, including: basic treatments such as glycemic control, anti-infection, and improvement of circulation
standard wound management for plantar ulcers
use of protective insoles or custom-made offloading shoes
medical education and lifestyle intervention.

Sponsors

Air Force Medical Center, PLA
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: Aged 18 to 80 years, meeting the World Health Organization (WHO) diagnostic criteria for diabetes; patients with Wagner grade I–II diabetic foot ulcers; presence of obvious flexion deformity of the toes, with plantar ulcers corresponding to the site of metatarsophalangeal high pressure; ankle-brachial index (ABI) >= 0.7 indicating acceptable arterial blood supply to the foot; signed informed consent and voluntary participation in this study.

Exclusion criteria

Exclusion criteria: Patients with foot infection requiring surgical debridement or amputation; those with severe lower limb arterial occlusion (ABI < 0.7) or requiring revascularization; those with serious cardiovascular or cerebrovascular diseases, liver or kidney failure, or other conditions making them unsuitable for surgery; those with coagulation disorders or on anticoagulant therapy; pregnant or lactating women; those with mental disorders or poor compliance.

Design outcomes

Primary

MeasureTime frame
ulcer recurrence rate;

Secondary

MeasureTime frame
changes in plantar pressure distribution;rate of complete healing of foot ulcers;wound healing time;postoperative complication rate;toe range of motion and structural changes;pain score;quality of life assessment;

Countries

China

Contacts

Public ContactDa Zhang

Air Force Medical Center, PLA

zhangda79@aliyun.com+86 134 8866 8972

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jun 11, 2026