Non-Invasive Assessment of Wound Healing With Optical Methods

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.

Study Overview

• Status: Completed
• Conditions: Diabetic Foot Ulcers
• Intervention / Treatment: Device: diffuse near infrared spectroscopy measurements

• Study Type: Observational
• Enrollment (Actual): 38

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19102
      • Drexel University College of Medicine Wound Care Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Recruited patients will be patients with diabetes who have chronic wounds and will likely have other co-morbidities associated with chronic diabetes.

Control subjects do not have diabetes and do not have wounds.

Description

Healthy Subject inclusion criteria

• Subjects must be 18-65 years of age
• Subjects must have no history of diabetes
• Subjects must have no history of vascular disease
• Subjects must have no findings of vascular disease on physical examination
• Subjects who are not allergic to Tegaderm

Patient Subject inclusion criteria:

• Subjects must be 18-65 years of age
• Subjects must have documented diabetes mellitus for at least 6 months.
• Subjects must have at least one documented chronic wound for a minimum 8 weeks.
• A chronic wound is defined as any wound that has not healed after 8 weeks and has a minimum surface area of 1cm2. There is no maximum wound size.
• Wound(s) must be secondary to the complications of diabetes, including vascular disease neuropathy, or both.
• Wounds must be on the ankles or feet
• Subjects who are not allergic to Tegaderm

EXCLUSION CRITERIA

• Subject must not be <18 or >65 years of age
• Subjects with major infections, abscesses, or untreated osteomyelitis will be excluded until appropriately treated.
• Subjects will not be excluded based upon the existence of other co-morbidities associated with chronic diabetes, including retinopathy, nephropathy, peripheral neuropathy, or cardiovascular disease except as follows:
• Subjects who have moderate to severe vascular insufficiency (defined as ankle brachial index <0.75 or toe-brachial index <0.5)
• Subjects who are unable to return for weekly follow-up appointments will not be included.
• Pregnant or lactating people will not be invited to participate.
• Subjects who are allergic to Tegaderm

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with a diabetic wound	Device: diffuse near infrared spectroscopy measurements; Measure blood flow to diabetic wounds
Control; Patients without a diabetic wound	Device: diffuse near infrared spectroscopy measurements; Measure blood flow to diabetic wounds

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
diffuse near infrared spectroscopy measurements	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.	3 years

Collaborators and Investigators

• Sponsor: Drexel University College of Medicine
• Investigators: Principal Investigator: Michael S Weingarten, M.D., Drexel University College of Medicine

Study record dates

Study Major Dates

• Study Start: September 1, 2007
• Primary Completion (Actual): June 1, 2014
• Study Completion (Actual): June 1, 2014

Study Registration Dates

• First Submitted: December 20, 2007
• First Submitted That Met QC Criteria: December 20, 2007
• First Posted (Estimate): December 21, 2007

Study Record Updates

• Last Update Posted (Actual): March 30, 2017
• Last Update Submitted That Met QC Criteria: March 28, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Endocrine System Diseases; Diabetic Angiopathies; Leg Ulcer; Skin Ulcer; Diabetes Complications; Diabetes Mellitus; Diabetic Neuropathies; Foot Diseases; Diabetic Foot; Foot Ulcer
• Other Study ID Numbers: 17035