The Effect of Negative Pressure Wound Therapy on Wound Healing in Major Amputations of the Lower Limb

Last updated: June 9, 2026
Sponsor: University of Southern Denmark
Overall Status: Completed

Phase

N/A

Condition

Vascular Diseases

Diabetes Prevention

Diabetes And Hypertension

Treatment

Standard care

PICO VAC

Clinical Study ID

NCT04618406
SHS-KI-09-2020
  • Ages > 18
  • All Genders

Study Summary

The socioeconomic costs of problematic and delayed wound healing following lower limb amputations are enormous to the society. Lower limb amputations is one of the longest known surgical treatments, but also one of the least investigated in the field of medical science. Negative Pressure Wound Therapy (NPWT) has emerged as a great instrument to aid healing. Studies have shown that it has a positive and measurable effect on wound healing following eg. total Knee and hip replacements. The aim of this study is to evaluate the effect of a closed NPWT on incidence of postoperative wound complications, in patients undergoing lower extremity amputation.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients undergoing transfemoral, knee disarticulations and transtibial amputationsby non-traumatic indication

  • Uni or bilateral amputations or re-amputations

Exclusion

Exclusion Criteria:

  • Patients undergoing traumatic amputations

  • Unwilling or unable to provide informed consent

  • Inability to comply with planned study procedures

  • Amputations due to malignancy

Study Design

Total Participants: 158
Treatment Group(s): 2
Primary Treatment: Standard care
Phase:
Study Start date:
November 01, 2021
Estimated Completion Date:
May 01, 2025

Study Description

Historically lower limb amputations have been performed to treat infection or trauma, usually in the setting of war. Today however major amputations of the lower extremities (transfemoral- (TFA), knee disarticulations (KD) and transtibial amputations (TTA)) are, in developed countries, usually performed in elderly patients with untreatable vascular disease, diabetes or a combination of both. This fragile group of patients are characterized by a high degree of comorbidity, mortality and both surgical and postoperative complications; included herein problems with wound healing. The tissue is typically poorly vascularized and prone to wound break-down, infections, necrosis etc. 10-40% of patients undergoing TFA, KD or TTA have delayed wound healing and/or insufficient wound healing, resulting in problems with the aftercare, mobilization with a prosthesis and re-amputations. Recent retrospective studies show that Negative Pressure Wound Therapy (NPWT) may have beneficial effects on incisional healing following lower limb amputations. However to our knowledge it has never been reproduced in a prospective randomized controlled setting.The aim of this study is to investigate the effect of NPWT with a PICO®️ device (Smith & Nephew) on the healing of the surgical wound following TFA, KD and TTA.

Connect with a study center

  • Sygehus Soenderjylland

    Aabenraa, 6200
    Denmark

    Site Not Available

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