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 @ 11:36 PM
Ignite Modification Date:
2025-12-24 @ 11:36 PM
NCT ID:
NCT02626156
Eligibility Criteria:
Inclusion Criteria:
* Newly healed leg or diabetic foot ulcer within past 7 - 14 days
* Ankle brachial index 0.8- 1.3mmHg (rule out absence of arterial disease)
* Willing to wear compression stockings and appropriate footwear
* Working freezer
Exclusion Criteria:
* Open leg or foot ulcers
* Cognitive impairment: unable to recall 2 or more words or draw clock Mini-Cog™ for cognitive impairment
* Chronic inflammatory or vascular conditions where blood flow of skin may be impaired such as Lupus erythematosus, Raynaud's, scleroderma, end stage renal disease, chronic regional pain syndrome, multiple sclerosis, hypersensitivity to cold, on chemotherapy
* Unable to preform required protocol activities without assistance (return demonstration to study staff)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
50 Years
Study:
NCT02626156
Study Brief:
Protocol Section:
NCT02626156