Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 8:03 PM
Ignite Modification Date:
2025-12-24 @ 8:03 PM
NCT ID:
NCT00578604
Eligibility Criteria:
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
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT00578604
Study Brief:
Protocol Section:
NCT00578604