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Not yet recruitingNCT07438795INF-STUMP-PAINUpdated Jun 3, 2026

Post-Amputation Stump Infection as a Predictor of Persistent Residual Limb Pain: A Prospective Cohort Study

An observational study in Residual Limb Pain, Stump Pain and Post-Amputation Pain, sponsored by Ukrainian Society of Regional Anesthesia and Pain Therapy. Not yet recruiting. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-06-03.

Sponsored by Ukrainian Society of Regional Anesthesia and Pain Therapy · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
150
Ages
18 Years to 60 Years
Sex
All
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Residual Limb Pain
  • Stump Pain
  • Post-Amputation Pain
  • Surgical Site Infection
  • Phantom Limb Pain (PLP)

Keywords

  • Traumatic amputation
  • stump infection
  • residual limb pain
  • chronic pain
  • surgical site infection
  • blast injury
  • neuropathic pain
03

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
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.

Inclusion criteria

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

Exclusion criteria

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
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
150 participants (estimated)
Target follow-up
6 Months
Patient registry
Yes

Groups and cohorts

  • 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.

05

What researchers measure

Primary outcomes

  1. Persistent Clinically Significant Residual Limb Pain

    Presence of clinically significant residual limb pain defined as Numeric Rating Scale (NRS) ≥4 at rest or during movement at 3 months after amputation.

    Time frame: 3 months

Secondary outcomes

  1. Persistent Residual Limb Pain at 6 Months

    NRS ≥4 at rest or during movement at 6 months after amputation.

    Time frame: 6 months

06

Study locations

No study locations are listed for this record.

07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07438795
Lead sponsor
Ukrainian Society of Regional Anesthesia and Pain Therapy
Responsible party
Dmytro Dmytriiev (professor, Ukrainian Society of Regional Anesthesia and Pain Therapy) — Principal investigator
First posted
Feb 27, 2026
Start date
Jun 23, 2026 (estimated)
Primary completion
Jun 23, 2026 (estimated)
Completion
Dec 23, 2026 (estimated)
Last update
Jun 3, 2026

Study contacts

Dmytro Dmytriiev, PhD.Professor
Contact
mddmytriiev@gmail.com
+380674309449

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

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