3D Camera - Telemedical Foot Ulcer Treatment | NCT01870934

Studies
3D Camera - Telemedical Foot Ulcer Treatment

NCT01870934

Sponsor

Odense University Hospital

Status

Unknown status

Last Update Posted

Oct 29, 2013Estimated

Enrollment

36Estimated

Phase

Not provided

Conditions

Diabetes Mellitus
Foot Ulcers

Interventions

Camera

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
12-08-00621	Other Identifier	CIV-ID

Status Module

Record Verification Date

Oct 2013

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2013

Primary Completion Date

Nov 2013Estimated

Completion Date

Nov 2013Estimated

First Submitted Date

Jun 4, 2013

First Submission Date that Met QC Criteria

Jun 5, 2013

First Posted Date

Jun 6, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 28, 2013

Last Update Posted Date

Oct 29, 2013Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Johnny Froekjaer, Research responsible Chief Surgeon, Odense University HospitalPrincipal Investigator

Lead Sponsor

Odense University HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Diabetic foot ulcers are deep wounds that occur as a result of nerve damage in the feet (peripheral neuropathy). Amputation is a common consequence of diabetic foot ulcers; approximately 85% of all diabetes-related amputations are caused by foot ulcers. The ulcer treatment is extensive, resource demanding and highly specialized and necessitates involvement of patient, hospital and local in-home care personnel.

The 3D photo optic camera project aims at a much more efficient and precise method for diagnosis and treatment of foot ulcers. The Department of Endocrinology and the section for LEAN and Innovation at Odense University Hospital has developed a prototype for a 3D camera that takes pictures and measurements of the ulcer that can provide the basis for correct diagnosis and treatment of the ulcer. The camera was developed in close cooperation with TECCLUSTER A/S, Svendborg Municipality, Team Online and ComMed.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

36Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Telemedicine, Diabetes, foot ulcer			Device: Camera

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Camera	Device	No real intervention, but a comparison of different methods including the new medical device 3D camera.	Telemedicine, Diabetes, foot ulcer

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Comparison of 3D image and normal assessment of wounds		outcome measure is assessed in 2013

Secondary Outcomes

Measure	Description	Time Frame
Comparison of 3D and 2D image assessment of wounds		november 2013

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with diabetic foot ulcers, which has been the diagnosis, stratification (eg ischemia, neuropathy, etc.) and treatment according to current guidelines refer "Diabetic Foot Study Group". Age 18-90 years

Exclusion Criteria:

Superficial wounds (superficial skin defect with loss of substance in 5 x 5 mm)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Diabetic foot ulcers patients

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Benjamin Sc Rasmussen, M.D.	Contact			bsr@rsyd.dk
Benjamin Schnack Sc Rasmussen	Contact

Overall Officials

Name	Affiliation	Role
Benjamin Schnack Rasmussen, M.D	Odense University Hosptial	Principal Investigator
Knud Yderstræde, MD, Ph.d.	Odense University Hospital	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Odense University Hospital	Recruiting	Odense	Odense	5000	Denmark

Condition Browse Module

MeSH Terms

ID	Term
D003920	Diabetes Mellitus
D016523	Foot Ulcer

Ancestor Terms

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided