Non-Invasive Assessment of Wound Healing With Optical Methods

Completed

• Conditions: Diabetic Foot Ulcers
• Interventions: Device: diffuse near infrared spectroscopy measurements

• Registration Number: NCT00578604
• Lead Sponsor: Drexel University College of Medicine

Brief Summary

The objective of this project is to further the development of a non-invasive optically based NIR (Near Infrared) device to enable the quantitative diagnosis, monitoring and treatment optimization of chronic wounds (especially diabetic) in a clinical setting. The end goal of this project is a portable and compact device that would be simple to operate by minimally trained health care personnel. Our animal studies have shown that the early healing of chronic wounds can be characterized by absorption and scattering of light at near infrared wavelengths ranging from 680 nm to 950 nm. If our project is successful we will be providing the clinician the ability to predict if a wound is healing and if a particular treatment is successful in accelerating healing before any changes are observed by wound size contraction or other visible clinical signs. Our hope is that the fNIR optical device will provide conclusive therapeutic treatment information as early as 5 weeks after initial evaluation, before it would be obvious on gross examination of the patient.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-09
• Study First Submitted: 2007-12-20
• Study First Submitted QC: 2007-12-20
• Study First Posted: 2007-12-21
• Primary Completion: 2014-06
• Study Completion: 2014-06
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-28
• Last Update Posted: 2017-03-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with a diabetic wound	diffuse near infrared spectroscopy measurements	Patients with a diabetic wound
Control	diffuse near infrared spectroscopy measurements	Patients without a diabetic wound

Primary Outcome Measures

Name	Time	Method
diffuse near infrared spectroscopy measurements	3 years	The end goal of this project is a portable and compact device that would be simple to operate by minimally trained health care personnel and is comparable to SOC doppler.

Trial Locations

Locations (1)

Drexel University College of Medicine Wound Care Center; 🇺🇸 Philadelphia, Pennsylvania, United States