PRIMARY VERSUS DELAYED STUMP CLOSURE IN DIABETIC FOOT AMPUTATION

PATIENT OUTCOMES IN PRIMARY VERSUS DELAYED PRIMARY CLOSURE OF STUMP IN BELOW KNEE AMPUTATION FOR DIABETIC FOOT

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

TCTR

Registry ID

TCTR20260711004

Enrollment

220

Registered

2026-07-11

Start date

2025-01-01

Completion date

Unknown

Last updated

2026-08-03

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

Conditions

Diabetic foot infection requiring below knee amputation Postoperative complications

Interventions

Primary stump closure. Patients undergoing below-knee amputation with immediate closure of the stump at the time of surgery.,Delayed primary stump closure. Patients undergoing below-knee amputation in

Active Comparator Procedure/Surgery,Active Comparator Procedure/Surgery

Intervention group 1: Primary Stump closure ,Intervention group 2. Delayed primary stump closure

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1.All male or female diabetic patients aged 18-75 years of age. 2.Patients receiving treatment with oral medication or on insulin. 3.Patients presenting for below knee amputation of a single non-salvageable limb with infection below the level of amputation. 4.Patients willing to participate and provide informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients with advanced cardiac or respiratory disease. 2. Patients planned for a guillotine amputation. 3. Patients with inadequate skin cover for stump formation. 4. Patients lost to follow-up. 5. Patients unwilling to be included in the study.

Design outcomes

Primary

Measure	Time frame
Surgical site infection 7th and 28th postoperative day Pus discharge, foul smell or any signs of infection ,Length of hospital stay At discharge from hospital Total number of days from surgery to discharge from hospital ,Readmission due to infection Within 28 days of surgery Hospital records and follow-up visits for infection related readmission ,Need for stump revision surgery Within 28 days after surgery Assessment for requirements of additional surgical procedure based on clinical assessment ,28 days mortality Within 28 days after surgery Hospital records and follow-up information	—

Measure

Time frame

Surgical site infection 7th and 28th postoperative day Pus discharge, foul smell or any signs of infection ,Length of hospital stay At discharge from hospital Total number of days from surgery to discharge from hospital ,Readmission due to infection Within 28 days of surgery Hospital records and follow-up visits for infection related readmission ,Need for stump revision surgery Within 28 days after surgery Assessment for requirements of additional surgical procedure based on clinical assessment ,28 days mortality Within 28 days after surgery Hospital records and follow-up information

—

Secondary

Measure	Time frame
N/A N/A N/A	—

Countries

Pakistan

Contacts

Public ContactAbdul Wahid

Combined Military Hospital, Rawalpindi

Wahidmalik973@outlook.com923329851374

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026