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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.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record

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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
What is being tested?
Interface pressure
How many people
12 participants
Where
1 siteCanada
Study dates
1 Sep 2026to 31 Dec 2026
Phase
Observational

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.

Bernadette Nedelec, phD contact

5143981275

bernadette.nedelec@mcgill.ca

Canada1 site
  • Villa Medica Rehabilitation Centre

    Montreal, Quebec, H3G1Y5

    Bernadette Nedelec, PhD, 5143981275, bernadette.nedelec@mcgill.ca

Other trials in Canada

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 groups in NCT07850557
Study groupRoleWhat they receive
Prostheses wearerPerson 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.

  1. 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)
  1. 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)

  2. 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.

  1. First posted30 Sep 2026
  2. Study start1 Sep 2026 (estimated)
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

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)
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
30 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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