NCT02233179

Brief Summary

The aim of the study was to explore the association between activities of daily living ( measured using a body-worn sensor) on wound healing in diabetic patients. Since this was an exploratory study, there was no study hypothesis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
49

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

June 1, 2009

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

August 8, 2014

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 8, 2014

Completed
Last Updated

September 8, 2014

Status Verified

September 1, 2014

Enrollment Period

2.2 years

First QC Date

August 8, 2014

Last Update Submit

September 3, 2014

Conditions

Diabetic Foot

Keywords

Diabetic foot ulcer

Outcome Measures

Primary Outcomes (2)

  • Wound size

    Wound size was measured every week for 12 weeks

    12 weeks

  • Daily Physical Activities

    Recorded using a body-worn sensor and measured every 4 weeks for 2 days.

    12 weeks

Study Arms (2)

Removable Cast Walker

EXPERIMENTAL

An offloading device that can be removed by the patients

Device: Removable cast walker

Irremovable Cast Walker

ACTIVE COMPARATOR

A removable cast rendered irremovable using instant total contact cast, so patients cannot remove offloading device.

Device: Irremovable cast walker

Interventions

Removable cast walkerDEVICE

Offloading device that can be removed by patients.

Also known as: Cast walker from Ossur, Reykjavik, Iceland
Removable Cast Walker
Irremovable cast walkerDEVICE

Offloading device that cannot be removed by patients.

Also known as: Cast walker from Ossur, Reykjavik, Iceland
Irremovable Cast Walker

Eligibility Criteria

Age37 Years - 68 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age 18 or older with non-infected, non-ischemic foot ulcers
  • active neuropathic foot ulcer

You may not qualify if:

  • major foot amputation
  • active Charcot arthropathy
  • ankle brachial index of 0.5 or less
  • history of substance abuse within 6 months
  • inability to walk 20m

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Medical Center

Tucson, Arizona, 85724, United States

Location

MeSH Terms

Conditions

Diabetic Foot

Condition Hierarchy (Ancestors)

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

Study Officials

  • David G Armstrong, DPM, MD, PhD

    University of Arizona

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

August 8, 2014

First Posted

September 8, 2014

Study Start

June 1, 2009

Primary Completion

August 1, 2011

Study Completion

November 1, 2012

Last Updated

September 8, 2014

Record last verified: 2014-09

Locations

US(1)