NCT03041844

Brief Summary

The purpose of this study is to evaluate the effect of low frequency, low intensity ultrasound treatment on wound healing and health-related quality of life with a randomized clinical trial of patients with venous ulcers or diabetic ulcers.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

January 25, 2017

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 3, 2017

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2023

Completed
Last Updated

April 6, 2022

Status Verified

April 1, 2022

Enrollment Period

5.2 years

First QC Date

January 25, 2017

Last Update Submit

April 5, 2022

Conditions

Diabetic Foot UlcerVenous Ulcer

Keywords

therapeutic ultrasoundquality of life

Outcome Measures

Primary Outcomes (1)

  • Change in wound size

    Percentage change in wound size over 4 weeks

    4 weeks

Secondary Outcomes (5)

  • Wound closure

    16 weeks

  • Health Related Quality of Life (HRQOL)

    16 weeks, then 6 and 12 months after last treatment

  • Wound Quality of Life (WQOL)

    16 weeks

  • Wound oxyhemoglobin concentration change

    16 weeks

  • Microcirculatory blood flow index change

    16 weeks

Study Arms (2)

Low Frequency, Low Intensity Ultrasound

EXPERIMENTAL

Low Frequency, Low Intensity therapeutic ultrasound applied weekly for up to 16 weeks.

Device: Low Frequency, Low Intensity Ultrasound

Sham Ultrasound

SHAM COMPARATOR

Sham ultrasound applied weekly for up to 16 weeks.

Device: Sham Applicator

Interventions

Low Frequency, Low Intensity UltrasoundDEVICE

Therapeutic ultrasound (20 kHz, \<100 mW/cm2 spatial peak-temporal peak)

Low Frequency, Low Intensity Ultrasound
Sham ApplicatorDEVICE

Sham ultrasound applicator

Sham Ultrasound

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Have a venous ulcer (VU) or diabetic ulcer (DU) that has been documented for at least 8 weeks without complete re-epithelialization and is larger than 0.75 cm2 in size.
  • VUs must be present on the lower extremities non-weight-bearing areas.
  • DUs must be present on the ankle or foot and be secondary to complications from diabetes.
  • Patients with DUs must have a documented history of diabetes mellitus of at least six months.

You may not qualify if:

  • VUs secondary to any connective tissue disorder or blood dyscrasias.
  • Severe vascular insufficiency (ankle-brachial index lower than 0.75 or toe-brachial index below 0.5).
  • Active, untreated infection
  • Acute deep venous thrombosis
  • Cutaneous malignancy present on the involved extremity
  • Active (or past 6 months) cancer treatment
  • Presence of both a diabetic ulcer and a venous ulcer on the same extremity
  • Known allergy to Tegaderm (a polyurethane dressing)
  • Pregnant women
  • Individuals younger than 18 years of age regardless of emancipation status
  • Prisoners
  • Individuals unable to speak English, Spanish, or Mandarin
  • Adults unable to consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Temple University School of Podiatric Medicine

Philadelphia, Pennsylvania, 19107, United States

Location

MeSH Terms

Conditions

Diabetic FootVaricose Ulcer

Condition Hierarchy (Ancestors)

Diabetic AngiopathiesVascular DiseasesCardiovascular DiseasesFoot UlcerLeg UlcerSkin UlcerSkin DiseasesSkin and Connective Tissue DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System DiseasesDiabetic NeuropathiesVaricose Veins

Study Officials

  • Peter A Lewin, PhD

    Drexel University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 25, 2017

First Posted

February 3, 2017

Study Start

January 1, 2017

Primary Completion

March 1, 2022

Study Completion

March 1, 2023

Last Updated

April 6, 2022

Record last verified: 2022-04

Locations

US(1)