Skin Ulcers Treatment With an Handicraft Topical Device

Study Overview
=================
Brief Summary
-----------------
The aim of this study was to evaluate the efficacy of a handicraft topical device of negative pressure versus traditional healing treatment for skin ulcers in lower limbs; in patients with diabetes mellitus, venous stasis and arterial insufficiency.

Detailed Description
-----------------
The hypothesis of this trial is that the handicraft topical device of negative pressure is even better for the treatment of skin ulcers located in the lower limbs of patients with diabetes mellitus, venous stasis and arterial insufficiency. We anticipate that in a sample of 144 patients with ulcer, will heal or at least improve with this treatment

Official Title
-----------------
Effectiveness of Topical Negative Handicraft Device for Versus Traditional Conservative Treatment in Skin Ulcers Management in Lower Limb

Conditions
-----------------
Foot Ulcer, Varicose Ulcer

Intervention / Treatment
-----------------
* Procedure: drenovac handcrafted
* Procedure: Healing


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with cutaneous leg ulcers due to diabetes mellitus, venous stasis and arterial insufficiency requiring healing or tissue debrided sent to managing their disease to regional general hospital No. 17, Instituto Mexicano del Seguro Social, Benito Juárez, Quintana Roo. Patients of both sexes. Patients over 18 years. Patients that have basic laboratory at admission (complete blood count with differential). Patients with comorbidities associated as Diabetes Mellitus , Hypertension, stroke, heart disease, nephropathy, venous insufficiency and arterial insufficiency, etc. Exclusion Criteria: Hemodynamically unstable patients. Patients with septic shock from any source. Patients with deep skin ulcers with exposed some organ, data osteomyelitis, vascular-nervous exposure. Patients with secondary cutaneous ulcer enteral fistula. Patients with cutaneous ulcer or cancer tumors. Patients with cutaneous ulcer with active bleeding. Patients with cutaneous ulcer necrosis. Patients with cutaneous ulcer leishmania, insect bite. Patients with cutaneous ulcer burns. Patients who do not accept their participation in the study through informed consent.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: drenovac handcrafted<br>Patients treatment with the handicraft topical device negative pressure therapy Economic craft | Procedure: drenovac handcrafted<br>* under local anesthesia, sepsis and antisepsis, place sterile field, prepared area go out all devitalized or necrotic tissue using liquid soap surgical and irrigation back saline 0.9%. We introduce a device to distribute the negative pressure or vacuum on ulcer; conducted margins make recommendations 5-12 mm over the edge of the wound, applying negative pressure or vacuum retracted sponges, likewise for the spare fewer gauze was placed Sterile adhesive film covering the defect to seal the system cover adequately the probe output nelaton not to submit drain the system. Connect the probe to the sterile nelaton this hose and a suction system with pressure gauge, pressure -80-125 mmHg. Change it every 72 hours.<br>|
| Active Comparator: Healing<br>Patients who were managed with traditional conservative treatment. | Procedure: Healing<br>* Were handled as follows: Under local anesthesia, prior asepsis and antisepsis of the skin ulcer with iodinepovidone sterile fields are placed, we proceeded to debridement of all necrotic tissue or devitalized then a cure with liquid soap surgery was performed and was irrigated with 1000 cc of solution physiological 0.9%, and finally the ulcer was covered with sterile gauze. healing of skin ulcers were performed every 24 hours. the evolution of skin ulcers was evaluated every 3 days, requesting a differential valuing of clinical and biochemical form the aforementioned variables.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence of granulation tissue in skin ulcers. | Presence of granulation tissue in 50% of the wound | 10 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Leukocyte less than 11,000 mm3. | Leukocyte less than 11,000 mm3. | 10 days | 
| Temperature | less than 38 ° C temperature. | 10 days | 
| Breathing Rate | less than 20 rpm breathing rate. | 10 days | 
| Heart Rate | lower heart rate 90 bpm. | 10 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diabetic foot ulcer, Foot care, Wound management