preparation & evaluation of sildenafil emulgel for clinical evaluation of diabetic foot wound healing

Phase 3

Recruiting

• Conditions: Diabetic foot ulcer.; Type 2 diabetes mellitus with foot ulcer; E11.621

• Registration Number: IRCT20190810044500N14
• Lead Sponsor: Yazd University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 26 May 2021

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 52

Inclusion Criteria

Patients over 18 years old with type 1 or type 2 diabetes and hemoglobin A1C less than 10%
Adequate literacy to fill out a consent form, understand the study, use the drug, report pain and possible side effects

Exclusion Criteria

Gangren Foot
Osteomyelitis
Severe sepsis
A history of alcohol or substance abuse
History of chronic diseases such as cancer or congestive heart failure, ESRD, liver failure
Concomitant use of drugs that may have a negative impact on the wound healing process: Glucocorticoids, immunosuppressive drugs, cytotoxic drugs
Not taking the medicine correctly
Failure to sign written consent
Pregnant and lactating women
Complications with topical medication use
Failure to attend follow up sessions while receiving medication
Patients with a history of steroid, cytotoxic or immunosuppressive drugs
Patients taking oral atorvastatin

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The length of the overall recovery period. Timepoint: daily. Method of measurement: REEDA score (3-0).;Inflation. Timepoint: Day zero and the end of the first, second, third and fourth weeks. Method of measurement: REEDA score (3-0).;Redness. Timepoint: Day zero and the end of the first, second, third and fourth weeks. Method of measurement: REEDA score (3-0).;Decreased secretions. Timepoint: Day zero and the end of the first, second, third and fourth weeks. Method of measurement: REEDA score (3-0).

Secondary Outcome Measures

Name	Time	Method
The severity of the pain. Timepoint: Day zero and the end of the first, second, third and fourth weeks. Method of measurement: Based on Visual analogue scale (VAS) criterion.;Recovery percentage. Timepoint: Day zero and the end of the first, second, third and fourth weeks. Method of measurement: REEDA score (3-0).;Occurrence of side effects. Timepoint: At the end of the study. Method of measurement: Based on Morisky medication adherence scale.;Quality of Life. Timepoint: At the beginning and end of the study. Method of measurement: Based on 15 DQOL questionnaire.