Amputation StumpNCT07850557
Hypertrophic Scar Prosthetic Pressure in Burn Amputee
An observational study of Amputation Stump and Burn Injury, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
Trial summary
Amputation following burn injury is rare but complex, affecting predominantly younger individuals with extensive burns, particularly electrical injuries, and often resulting in residual limbs characterized by scarring, contractures, grafted or flapped tissues, and heightened vulnerability to skin breakdown. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Amputation Stump, Burn Injury, Pressure Distribution
- What is being tested?
- Interface pressure
- How many people
- 12 participants
- Where
- 1 siteCanada
- Study dates
- 1 Nov 2026to 31 Dec 2026
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Adult burn survivors with a major limb amputation who are admitted to or followed in the outpatient clinic at Villa Medica Rehabilitation Centre
Who may be able to join
- 1. Burn survivors aged 16 years and older who have sustained a major amputation secondary to a burn injury.
- 2. Participants must be fitted with a definitive prosthesis incorporating a socket (laminate- or carbon-based) and have received their final prosthetic components (e.g., prosthetic knee and/or foot).
- 3. Participants must be proficient in English and/or French and capable of providing informed consent
Who cannot join
- present dermatological conditions that may compromise measurement reliability (e.g., eczema, psoriasis).
- Participants with cognitive or psychiatric conditions that could impair comprehension of the consent process or adherence to study procedures will also be excluded
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site
Villa Medica Rehabilitation Centre
Montreal, Quebec, H3G1Y5
Bernadette Nedelec, PhD, 5143981275, bernadette.nedelec@mcgill.ca
About this study
Official title: Hypertrophic Scar Prosthetic Pressure in Burn Amputee: A Pilot Study
Amputation following burn injury is rare but complex, affecting predominantly younger individuals with extensive burns, particularly electrical injuries, and often resulting in residual limbs characterized by scarring, contractures, grafted or flapped tissues, and heightened vulnerability to skin breakdown. Prosthesis-covered burn scars often appear to heal better than uncovered areas, suggesting a potential therapeutic pressure effect; however, excessive localized peak pressures may also contribute to recurrent wounds in grafted or scarred tissues. This study aims to quantify prosthesis-induced pressures on the residual limbs of burn-injured amputees and evaluate the feasibility and reliability of applying pressure measurement tools validated in burn care to this distinct clinical context.
Read the detailed description
Amputation following burn injury is uncommon. Major amputations following burn injury differ substantially from those performed in diabetic or vascular populations: burn-injured amputees are generally healthier, residual limb segments are longer, muscle flaps create bulkier stumps, and the residual limbs often present with hypertrophic scarring and contractures.
However, multiple complications may develop in individuals with burn-related amputations, including residual limb pain, edema, sensory disturbances (hypo- or hypersensitivity), heterotopic ossification, and recurrent wounds.
Pressure therapy has been widely used in burn rehabilitation to treat hypertrophic scars. It is believed to promote scar maturation by reducing mechanical tension. However, no studies to date have quantified the pressures exerted on hypertrophic scars of amputees with burn injuries when wearing their prosthetic liner or full prosthesis. This knowledge gap is critical, as pressures exceeding 40 mmHg can compromise capillary perfusion and cause pain, blistering, or tissue necrosis, which are risks that are exacerbated in grafted or flapped tissues predisposing them to skin breakdown.
Studies conducted in non-burn amputee populations have demonstrated that pressure distribution within a prosthetic socket varies significantly depending on socket design and materials. Reported interface pressures typically range from 40 kPa to 250 kPa (approximately 300-1875 mmHg). Measurement conditions also influence results, as pressures differ during static standing compared with dynamic gait. Liner thickness further affects these values; for example, increasing liner thickness by 4 mm has been shown to reduce peak pressures by approximately 18%. These findings highlight the importance of assessing pressure under realistic conditions, with the complete prosthetic system in place.
Clinically, it is often observed that hypertrophic scars covered by a prosthesis tend to flatten, become less erythematous, and appear more mature than adjacent uncovered scars. This observation led to the current research question and the hypothesis that prosthetic-induced pressure exceeds the pressure that is generated by standard pressure garments. Furthermore, it raises the question of whether residual limb wounds in this population may result from localized peak pressures within the prosthetic socket.
The objective of this pilot study is to improve understanding of prosthesis-residual limb interactions in burn-injured amputees and to assess the feasibility of measuring these interactions using objective pressure assessment tools.
This study is a prospective, minimal-risk, pilot observational feasibility study using a repeated-measures design. The study involves non-invasive interface pressure measurements obtained under usual prosthetic use conditions in adults with burn-related amputations. No therapeutic intervention or modification to standard clinical care will be introduced. The primary objective is to quantify prosthesis-induced interface pressures at predefined residual limb sites. The secondary objectives are to evaluate the feasibility, reliability, and acceptability of pressure measurement tools in this specific clinical population.
- Being tested
- Skin assessment of prothesis interface and control area, Interface pressure
- Keywords
- Prosthetic, Pressure, Hypertrophic scar, burn injuries, amputee
- Medical subject headings
- Burns, Pressure Ulcer, Cicatrix, Hypertrophic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Skin assessment of prothesis interface and control areaOther
Evaluation of Melamin and erythema (Mexameter), TEWL ( Tewameter), skin elasticity (Cutometer), skin thickness (Dermascan)
Interface pressureOther
Mean and peak interface pressure (limb to prosthetic)
| Study group | Role | What they receive |
|---|---|---|
| Prostheses wearer | Person must have a amputated stump with a prothese, caused by burn injuries. The evaluated zone can include hypertrophic scar (HSc) sites, flaps, wounds, areas of localized pain, the distal residuum, bony prominences, and soft tissue regions in prosthetic interface. The control zone is a normal skin area of the same person. Receives: Other: Skin assessment of prothesis interface and control area; Other: Interface pressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prosthetic-induced interface pressure
quantification of interface pressure (mmHg) at predefined residual limb sites in burn-related amputees, assessing within-subject differences in interface pressure
Measured: From enrollment to end of visit (2 hours)
Secondary outcomes (2)
Feasibility outcomes
Determine procedural feasibility and inform the design of a future powered study. - Recruitment rate
- Completion rate
- Proportion of usable pressure recordings
- Time required for full assessment per participant
- Sensor placement success rate
- Incidence of adverse events
Measured: across all participants data collection period (three years)
Association Between Skin Characteristics and Interface Pressure
Associations between:
- Skin thickness
- Elasticity
- Transepidermal water loss
- Melanin and erythema indices
- Mean and peak interface pressure values
Measured: From enrollment to end of visit (2 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2026
- Study start1 Nov 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Amputation StumpStudies of the same condition, open and under way.
- More trials run by Centre hospitalier de l'Université de Montréal (CHUM)The sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Quebec Firefighters Foundation for Burns
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07850557
- Sponsor's protocol ID
- 2027-13830
- Status last verified
- Jul 2026
- First submitted
- 18 Sep 2026
- Last updated
- 2 Nov 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 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hypertrophic Scar Prosthetic Pressure in Burn Amputee: A Pilot Study
- ClinicalTrials.gov ID
- NCT07850557
- Acronym / sponsor ID
- 2027-13830
- Keywords
- Prosthetic, Pressure, Hypertrophic scar, burn injuries, amputee
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)University, hospital or other
- Collaborators
- Quebec Firefighters Foundation for Burns
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 30 Sep 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.
Amputation following burn injury is rare but complex, affecting predominantly younger individuals with extensive burns, particularly electrical injuries, and often resulting in residual limbs characterized by scarring, contractures, grafted or flapped tissues, and heightened vulnerability to skin breakdown. Prosthesis-covered burn scars often appear to heal better than uncovered areas, suggesting a potential therapeutic pressure effect; however, excessive localized peak pressures may also contribute to recurrent wounds in grafted or scarred tissues. This study aims to quantify prosthesis-induced pressures on the residual limbs of burn-injured amputees and evaluate the feasibility and reliability of applying pressure measurement tools validated in burn care to this distinct clinical context.
Detailed description
Amputation following burn injury is uncommon. Major amputations following burn injury differ substantially from those performed in diabetic or vascular populations: burn-injured amputees are generally healthier, residual limb segments are longer, muscle flaps create bulkier stumps, and the residual limbs often present with hypertrophic scarring and contractures.
However, multiple complications may develop in individuals with burn-related amputations, including residual limb pain, edema, sensory disturbances (hypo- or hypersensitivity), heterotopic ossification, and recurrent wounds.
Pressure therapy has been widely used in burn rehabilitation to treat hypertrophic scars. It is believed to promote scar maturation by reducing mechanical tension. However, no studies to date have quantified the pressures exerted on hypertrophic scars of amputees with burn injuries when wearing their prosthetic liner or full prosthesis. This knowledge gap is critical, as pressures exceeding 40 mmHg can compromise capillary perfusion and cause pain, blistering, or tissue necrosis, which are risks that are exacerbated in grafted or flapped tissues predisposing them to skin breakdown.
Studies conducted in non-burn amputee populations have demonstrated that pressure distribution within a prosthetic socket varies significantly depending on socket design and materials. Reported interface pressures typically range from 40 kPa to 250 kPa (approximately 300-1875 mmHg). Measurement conditions also influence results, as pressures differ during static standing compared with dynamic gait. Liner thickness further affects these values; for example, increasing liner thickness by 4 mm has been shown to reduce peak pressures by approximately 18%. These findings highlight the importance of assessing pressure under realistic conditions, with the complete prosthetic system in place.
Clinically, it is often observed that hypertrophic scars covered by a prosthesis tend to flatten, become less erythematous, and appear more mature than adjacent uncovered scars. This observation led to the current research question and the hypothesis that prosthetic-induced pressure exceeds the pressure that is generated by standard pressure garments. Furthermore, it raises the question of whether residual limb wounds in this population may result from localized peak pressures within the prosthetic socket.
The objective of this pilot study is to improve understanding of prosthesis-residual limb interactions in burn-injured amputees and to assess the feasibility of measuring these interactions using objective pressure assessment tools.
This study is a prospective, minimal-risk, pilot observational feasibility study using a repeated-measures design. The study involves non-invasive interface pressure measurements obtained under usual prosthetic use conditions in adults with burn-related amputations. No therapeutic intervention or modification to standard clinical care will be introduced. The primary objective is to quantify prosthesis-induced interface pressures at predefined residual limb sites. The secondary objectives are to evaluate the feasibility, reliability, and acceptability of pressure measurement tools in this specific clinical population.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prostheses wearer | – | Other: Skin assessment of prothesis interface and control area, Other: Interface pressurePerson must have a amputated stump with a prothese, caused by burn injuries. The evaluated zone can include hypertrophic scar (HSc) sites, flaps, wounds, areas of localized pain, the distal residuum, bony prominences, and soft tissue regions in prosthetic interface. The control zone is a normal skin area of the same person. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Adult burn survivors with a major limb amputation who are admitted to or followed in the outpatient clinic at Villa Medica Rehabilitation Centre
Key inclusion criteria (3 listed)
- 1. Burn survivors aged 16 years and older who have sustained a major amputation secondary to a burn injury.
- 2. Participants must be fitted with a definitive prosthesis incorporating a socket (laminate- or carbon-based) and have received their final prosthetic components (e.g., prosthetic knee and/or foot).
- 3. Participants must be proficient in English and/or French and capable of providing informed consent
Key exclusion criteria (2 listed)
- present dermatological conditions that may compromise measurement reliability (e.g., eczema, psoriasis).
- Participants with cognitive or psychiatric conditions that could impair comprehension of the consent process or adherence to study procedures will also be excluded
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Skin assessment of prothesis interface and control areaEvaluation of Melamin and erythema (Mexameter), TEWL ( Tewameter), skin elasticity (Cutometer), skin thickness (Dermascan) | Other | Prostheses wearer |
| Interface pressureMean and peak interface pressure (limb to prosthetic) | Other | Prostheses wearer |
Primary outcome
Prosthetic-induced interface pressure
Time frame: From enrollment to end of visit (2 hours)
quantification of interface pressure (mmHg) at predefined residual limb sites in burn-related amputees, assessing within-subject differences in interface pressure
2 secondary outcomes
Feasibility outcomes
Time frame: across all participants data collection period (three years)
Association Between Skin Characteristics and Interface Pressure
Time frame: From enrollment to end of visit (2 hours)
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 2 Nov 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Amputation Stump and Burn Injury, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
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 2 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 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Bernadette Nedelec, phD (5143981275, bernadette.nedelec@mcgill.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prosthetic-induced interface pressure (time frame: From enrollment to end of visit (2 hours)). 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 2 Nov 2026.