Residual Limb PainINF-STUMP-PAINNCT07438795
Post-Amputation Stump Infection as a Predictor of Persistent Residual Limb Pain: A Prospective Cohort Study
An observational study of Residual Limb Pain and Stump Pain, run by Ukrainian Society of Regional Anesthesia and Pain Therapy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Residual Limb Pain, Stump Pain, Post-Amputation Pain
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 23 Jun 2026to 23 Dec 2026
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
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.
Who may be able to join
- Traumatic upper or lower limb amputation
- Enrollment within 4 weeks after surgery
- Ability to provide informed consent
Who cannot join
- Pre-existing chronic pain in the affected limb
- Severe cognitive impairment
- Terminal illness limiting follow-up
- Refusal or inability to complete follow-up assessments
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
- Conditions
- 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
- Medical subject headings
- Surgical Wound Infection, Phantom Limb, Amputation, Traumatic, Chronic Pain, Blast Injuries, Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Secondary outcomes (1)
Persistent Residual Limb Pain at 6 Months
NRS ≥4 at rest or during movement at 6 months after amputation.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study start23 Jun 2026 (estimated)
- Primary completion23 Jun 2026 (estimated)
- Study completion23 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Residual Limb PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Ukrainian Society of Regional Anesthesia and Pain Therapy
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dmytro Dmytriiev, Ukrainian Society of Regional Anesthesia and Pain Therapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07438795
- Sponsor's protocol ID
- 23V0223022026
- Other IDs
- USRA
- Acronym
- INF-STUMP-PAIN
- Status last verified
- Jun 2026
- First submitted
- 22 Feb 2026
- Last updated
- 3 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Amputation Stump Infection as a Predictor of Persistent Residual Limb Pain: A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT07438795
- Acronym / sponsor ID
- INF-STUMP-PAIN / 23V0223022026
- Conditions
- 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
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Ukrainian Society of Regional Anesthesia and Pain TherapyUniversity, hospital or other
- Study start
- 23 Jun 2026 (estimated)
- Primary completion
- 23 Jun 2026 (estimated)
- Study completion
- 23 Dec 2026 (estimated)
- First posted
- 27 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (3 listed)
- Traumatic upper or lower limb amputation
- Enrollment within 4 weeks after surgery
- Ability to provide informed consent
Key exclusion criteria (4 listed)
- Pre-existing chronic pain in the affected limb
- Severe cognitive impairment
- Terminal illness limiting follow-up
- Refusal or inability to complete follow-up assessments
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
Persistent Residual Limb Pain at 6 Months
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Residual Limb Pain and Stump Pain, run by Ukrainian Society of Regional Anesthesia and Pain Therapy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dmytro Dmytriiev, PhD.Professor (+380674309449, mddmytriiev@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Persistent Clinically Significant Residual Limb Pain (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2026.