Those patients that will be treated by NPWT.

Those patients will be treated with standard saline moist wound care and dressing.

Diabetic Foot Ulcer

VAC was applied by placing sterile pads in two layers with a 16Fr Ryle's tube placed between the two layers and then the wound was sealed by a sterile transparent polyurethane sheet. The tube was connected to a wall-mounted suction device and the pressure will be set at −125 mmHg Mode of NPWT. This dressing will be changed every 72 hrs

Negative Pressure Wound Therapy

Negative Pressure Wound Therapy in the Management of Diabetic Foot Ulcers

Role of Negative Pressure Wound Therapy in the Management of Diabetic Foot Ulcers

Assessment role of negative pressure wound therapy in treating diabetic foot ulcers.

Abdelrahman Ibrahim Sayed

Vascular Surgery Department, Assiut University

Assiut University

The comparison drug is placebo, which is made with same size and shape with study drug. DLBS1033 and placebo is produced by PT Dexa Medica. Placebo will taken 3 times 1 tablet per day for 7 days. Wash out period before enter another arm is 7 days.

The study drug is enteric coated DLBS1033, which contain 490 mg bioactive protein fraction. The drug will taken 3 times 490 mg per day for 7 days. Wash out period before enter another arm is 7 days.

Healthy

The study drug is enteric coated DLBS1033, which contain 490 mg bioactive protein fraction.

DLBS1033

Placebo is made with same size and shape with study drug.

placebo

Indonesia University

The Effects of DLBS1033 on Haemostasis Parameters in Healthy Volunteers

changes in activated partial thromboplastin time

changes in serum glutamic oxaloacetic transaminase

changes in serum glutamic pyruvic transminase

Nafrialdi

MD, PhD, SpPD, SpFK

Dexa Medica Group

Application of acoustical pulse energy (extracorporeal shockwaves) to target ulcer + standard of care

Non-energized (inactive - Sham)) application + standard of care

dermaPACE: dermaPACE + Standard of care wound dressing.

dermaPACE Application + Standard of Care

Sham: Sham treatment (non-energized, inactive device) + Standard of care wound dressing.

Non-energized (Inactive) Application + Standard of Care

Total

Sex: Female, Male

Region of Enrollment

dermaPACE application + standard of care
dermaPACE: dermaPACE + Standard of care wound dressing.

Non-energized (inactive) application + standard of care
Sham: Sham treatment + Standard of care wound dressing.

The Primary Variable for Effectiveness of the dermaPACE Device Will be Assessed by Comparing the Incidence of Complete Wound Closure of the dermaPACE and Control Groups 12 Weeks Post Initial Application.

Time to Wound Closure, Wound Closure Area and Volume Between Active and Control 12 Weeks Post Initial Application, Subject Pain Assessment Between Active and Control 24 Weeks Post Initial Application

Overall Study

Dr. Daniel Jorgensen, MD

Diabetic Foot Ulcers

Acoustical pulse energy (extracorporeal shockwave) + Standard of care wound dressing.

acoustical pulse energy (extracorporeal shockwave)

Non-energized (inactive - Sham) application + standard of care

diabetic foot/protease

Negative Pressure Wound Therapy in the Management of Diabetic Foot Ulcers

The Effects of DLBS1033 on Haemostasis Parameters in Healthy Volunteers

Effectiveness of dermaPACE™ Device and Standard Treatment Compared to Standard Treatment Alone for Diabetic Foot Ulcers

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