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:
2025-12-25 @ 1:26 AM
Ignite Modification Date:
2025-12-25 @ 1:26 AM
NCT ID:
NCT02332993
Eligibility Criteria:
Inclusion Criteria:
* Patients 30 - 70 years
* Patient must understand and give written informed consent
* Patient must be a Type II Diabetic
* HbA1c ≤9%
* Receiving Negative Pressure Therapy (NPWT)
One or more of the following:
* Transcutaneous Oxygen Measurement \>30 mmHg
* ABI (Ankle-Brachial Index) \>0.7 and less 1.3
* Toe Pressures \>30 mmHg
Exclusion Criteria:
* Individuals who are deemed unable to understand the procedures, risks and benefits of the study, i.e. Informed consent will be excluded.
* Patients who are pregnant (all women of childbearing age will have a urine Hcg test upon enrollment and agree upon one of the following forms of contraception for the duration of the study: Abstinence, Hormonal contraception, spermicidal condoms, or either you or your partner having been surgically sterilized)
* Immuno-compromised patients; receiving radiation therapy, chemo, or have gone through transplantation or other conditions with prolonged steroid use
* Patients with clinical signs of soft tissue infection such as fever, erythema, leukocytosis, purulent drainage.
* Antibiotic use 7 days prior to biopsy and cultures
* Current smoker
* Clinically significant kidney or liver disease (dialysis)
* Severe neurologic dysfunction
Females who are pregnant as well as individuals who are therapeutically immuno-compromised will also be excluded in order to minimize the risk to such individuals (and fetus) and to decrease statistical variability and to minimize potential of confounders.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
30 Years
Maximum Age:
30 Years
Study:
NCT02332993
Study Brief:
Protocol Section:
NCT02332993