Non-Invasive Assessment of Wound Healing With Optical Methods

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.

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