Health TrialsbyHealthPanel

Diabetes Related Foot Ulcers With Negative Pressure Wound Therapy

ConditionDiabetic Foot Ulcer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Akershus

About this trial

The goal of this study is to learn if the clinical effects of Negative Pressure Wound Therapy (NPWT) is better, worse or the same as standard wound care for patients with diabetic foot ulcers (DFUs).

The main questions it aims to answer are:

* Will there be a difference in the number of major amputations between the groups during the first year? * Will one of the treatments require more surgeries and longer hospital stays?

All participants will:

* be treated with NPWT or standard wound care for their diabetic foot ulcer after surgery * be followed closely at the out-patient clinic for one year after treatment

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Male and non-pregnant female above 18 years with a diabetic foot ulcer in need of surgical debridement or forefoot amputation

Disqualifiers

Previous leg amputation due to diabetes

Unable to ambulate on feet

Unlikely to adhere to treatment and/or follow-up

Unable to complete questionnaire

Trial design

Design model

Parallel

Treatments tested in this trial

  • Negative Pressure Wound Treatment

    Procedure/Surgery

    Negative Pressure Wound Treatment promotes healing by applying subatmospheric pressure to reduce inflammatory exudate and stimulate granulation tissue.

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Standard Wound TreatmentNo intervention 0 interventions
Group B: Negative Pressure Wound TreatmentActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Number of lower extremity amputations

The study will compare rates of lower extremity amputations within one year after two different treatments for diabetes related foot ulcers.

Time frame
One year from inclusion

Secondary outcomes

1

Mortality

Mortality rate during the study period.

Time frame
One year.
2

Wound healing

Wound healing during the study period.

Time frame
One year.
3

Complications

Rate of the following complications; * Death within 30 days postoperatively likely related to the DFU * Major bleeding necessitating acute resuscitation, massive blood transfusion, or any additional vascular procedure to stop the bleeding. * Any reoperation within 90 days of the index trial surgery, due to deep wound infection, osteomyelitis or sepsis * Pulmonary embolism (PE) * Acute myocardial infarction (AMI) * Postoperative organ failure or worsening of pre-existing organ failure necessitating organ support or ICU stay

Time frame
One year.
4

Number of surgeries

Number of surgeries during the study period.

Time frame
One year.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospital, Akershus

Lead sponsor

South-Eastern Norway Regional Health Authority

Collaborator

University of Oslo

Collaborator

Ostfold Hospital Trust

Collaborator

Source ClinicalTrials.gov
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