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 @ 2:22 AM
Ignite Modification Date:
2025-12-25 @ 2:22 AM
NCT ID:
NCT02691234
Eligibility Criteria:
* Inclusion Criteria:
1. Chronic non-healing diabetic foot ulcers for more than 2 months.
2. Age 18-80 years
3. Ankle Brachial Index (ABI) ≥0.6
4. Diabetic Foot Ulcer with the long diameter of ≤7cm and a short diameter of ≥1cm
5. The target ulcer is up to Wagner's grade 3
6. Albumin level ≥25g/L
7. Hemoglobin level ≥90g/L
8. Estimated Glomerular Filtration Rate (eGFR) ≥30ml/min/1.73m2
9. The patient agrees to comply with study protocol requirements, including the shockwave procedure, self-care of the ulcer (dressings, orthotics etc.) and all follow-up visit requirements
* Exclusion Criteria:
1. Pregnancy or lactation
2. ABI \<0.6
3. The long diameter of the target ulcer is \>7cm and the short diameter is \<1cm
4. The target ulcer is of Wagner's grade 4 or above
5. Severe Hypoalbuminemia \<25g/L
6. Severe anemia, Hemoglobin level \<90g/L
7. eGFR \<30ml/min/1.73m2
8. Patients suffering from acute Charcot foot
9. Severe edema of the treated limb
10. Patient with present malignancy or past malignancy in the treated area
11. Systemic chemotherapy/ radiation treatment within the last 6 months
12. Deep vein thrombosis within the last 6 months
13. Any other experimental treatment or participation in other studies
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Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT02691234
Study Brief:
Protocol Section:
NCT02691234