Post-Amputation Stump Infection as a Predictor of Persistent Residual Limb Pain: A Prospective Cohort Study (INF-STUMP-PAIN)

June 1, 2026 updated by: Dmytro Dmytriiev, Ukrainian Society of Regional Anesthesia and Pain Therapy
Persistent residual limb pain is common after traumatic amputation and significantly impairs rehabilitation and prosthetic use. Postoperative stump infection may contribute to peripheral nerve sensitization, scar fibrosis, and long-term pain persistence. This prospective cohort study aims to determine whether early post-amputation stump infection independently predicts persistent clinically significant residual limb pain at 3 and 6 months after surgery.

Study Overview

Status

Not yet recruiting

Conditions

Detailed Description

Patients undergoing traumatic limb amputation will be enrolled within 4 weeks after surgery and followed for 6 months. Early postoperative stump infection will be recorded using predefined clinical criteria. Pain intensity (Numeric Rating Scale), neuropathic pain screening (DN4), and phantom limb pain will be assessed at baseline, 3 months, and 6 months. Multivariable logistic regression will be used to evaluate whether stump infection is independently associated with persistent residual limb pain, adjusting for amputation level, injury mechanism, revision surgeries, antibiotic exposure, and demographic factors.

Study Type

Observational

Enrollment (Estimated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The study population will consist of adult patients (≥18 years) undergoing traumatic upper or lower limb amputation following blast-related, drone-related, or other high-energy injuries. Participants will be enrolled within 4 weeks after primary amputation surgery and followed prospectively for 6 months. The population represents individuals at risk of developing persistent residual limb pain during the early postoperative and rehabilitation period.

Description

Inclusion Criteria:

  • Traumatic upper or lower limb amputation
  • Enrollment within 4 weeks after surgery
  • Ability to provide informed consent

Exclusion Criteria:

  • Pre-existing chronic pain in the affected limb
  • Severe cognitive impairment
  • Terminal illness limiting follow-up
  • Refusal or inability to complete follow-up assessments

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Stump Infection
Participants who develop postoperative stump infection within 30 days after amputation, defined by clinical signs of infection requiring antibiotic therapy and/or surgical revision.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Persistent Clinically Significant Residual Limb Pain
Time Frame: 3 months
Presence of clinically significant residual limb pain defined as Numeric Rating Scale (NRS) ≥4 at rest or during movement at 3 months after amputation.
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Persistent Residual Limb Pain at 6 Months
Time Frame: 6 months
NRS ≥4 at rest or during movement at 6 months after amputation.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ukrainian Society of Regional Anesthesia and Pain Therapy

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 23, 2026

Primary Completion (Estimated)

June 23, 2026

Study Completion (Estimated)

December 23, 2026

Study Registration Dates

First Submitted

February 22, 2026

First Submitted That Met QC Criteria

February 22, 2026

First Posted (Actual)

February 27, 2026

Study Record Updates

Last Update Posted (Actual)

June 3, 2026

Last Update Submitted That Met QC Criteria

June 1, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 23V0223022026
  • USRA (Other Identifier: Ukranian Society of Regional Anesthesia and Pain Therapy)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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