Blockade of mini-TrpRS for treatment of diabetic foot syndrome: A Prospective open-label phase 1a/1b randomized placebo-controlled trial.

Phase 1

• Conditions: Diabetic Foot Ulcers; Skin - Other skin conditions; Metabolic and Endocrine - Diabetes

• Registration Number: ACTRN12621000120875
• Lead Sponsor: Townsville University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-02-08
• Last Update Posted: 16 February 2021

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 112

Inclusion Criteria

Inclusion Criteria:
1.Subjects greater than or equal to 18 years of age diagnosed with type 2 diabetes on diet only or any diabetic medication regime.
2.Existing diabetes index foot ulcer grade A1 or higher according to the University of Texas Wound Classification System of Diabetic Foot Ulcers on the day of study inclusion. A foot ulcer is defined as any full-thickness skin defect existing for at least 14 days. In patients with multiple diabetic foot ulcers, the index foot ulcer is defined as the foot ulcer with the largest wound area at the time of inclusion

Exclusion Criteria

Exclusion Criteria:
1)Type 1 Diabetes.
2)Current index foot ulcer of any non-diabetic pathophysiology (e.g. rheumatoid, radiation-related, vasculitis-related, calciphylaxis, or dystrophic calcinosis cutis, etc.).
3)Any major surgery up to 6 months before the day of enrolment or any planned surgery before study completion, including any major surgical intervention for the diabetic foot ulcer.
4)Significant medical conditions that potentially impair wound healing and/or alter the concentration of serum immune markers including hepatic, respiratory or cardiac failure, aplastic anemia, autoimmune diseases (e.g., Lupus erythematosus, scleroderma, etc.), chronic inflammatory diseases (e.g., inflammatory bowel disease, inflammatory or rheumatoid arthritis, etc.) and any active malignancies including cancerous or pre-cancerous lesions in the ulcer area other than basal cell carcinoma.
5)Any concomitant medication which could potentially alter the concentration of serum immune markers during the study including systemic cortocosteroids, immunosuppressants, chemotherapeutic agents, growths factor products, etc.
6)Skin and dermal substitutes within 30 days before study enrolment.
7)Enzymatic debridement treatment.
8)Active Charcot's foot as determined by clinical and radiographic examination.
9)Significant renal impairment (eGFR < 30 ml/min).
10)Pregnancy, lactation or child-bearing potential. Women must be either of non-childbearing potential as defined in the protocol or must have a negative pregnancy test on the day of study inclusion or randomization and agree to use an adequate method of contraception as defined in the protocol for at least until two weeks after taking the last dose of study medication. Also, men who take part in this study should genuinely not plan to get their partners pregnant (no active family planning) while participating in this study and until 14 days after taking the last dose of study medication.
11)Participation in any other clinical trial.
12)Inability to comply with study protocol.
13)Any current or new contraindication, special warning, precaution or other patient safety-related concern relevant to the patient at the time of enrolment as listed in the current product information.

Study & Design

• Study Type: Interventional
• Study Design: Not specified