23/01/2024
Men or women aged 18 years old or older, with type 1 or 2 diabetes mellitus.
2. Single full-thickness plantar ulcer of the extremity (below the malleolus) extending through the epidermis and dermis, but not involving bone, tendons, ligaments or muscles (grade IA or II as defined by University of Texas Diabetic Wound Classification).
3. Chronic ulcer of at least six weeks despite appropriate wound care.
4. Ulcer area (greatest length by greatest width), following sharp debridement, of 1 to 10 cm², both inclusive.
5. Well controlled infection or cellulitis (with systemic antibiotic therapy).
6. Peripheral neuropathy as assessed by Semmes-Weinstein monofilament test
7. Adequate arterial blood supply, to be measured by (color) doppler ultrasonography, ankle brachial pressure index > 0.60, OR ankle systolic pressure > 70 mmHg OR toe pressure > 30 mmHg. Ankle brachial pressure index should be lower than 1.3 (which is frequently related to medial artery calcification.
8. Women surgically sterile, post-menopausal, or agree to practice adequate contraception and have a negative pregnancy test at screening. Non-nursing.
9. Willing to provide written informed consent before any study procedure
People who are suffering from above
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