Skin Ulcers Treatment With an Handicraft Topical Device

Phase 4

Completed

• Conditions: Varicose Ulcer; Foot Ulcer
• Interventions: Procedure: drenovac handcrafted; Procedure: Healing

• Registration Number: NCT02512159
• Lead Sponsor: Coordinación de Investigación en Salud, Mexico

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

Study Timeline

• Status Verified: 2014-02
• Study Start: 2014-03
• Primary Completion: 2014-10
• Study Completion: 2015-01
• Study First Submitted: 2015-03-12
• Study First Submitted QC: 2015-07-29
• Last Update Submitted: 2015-07-29
• Study First Posted: 2015-07-30
• Last Update Posted: 2015-07-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 144

Inclusion Criteria

1. 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.
2. Patients of both sexes.
3. Patients over 18 years.
4. Patients that have basic laboratory at admission (complete blood count with differential).
5. Patients with comorbidities associated as Diabetes Mellitus , Hypertension, stroke, heart disease, nephropathy, venous insufficiency and arterial insufficiency, etc.

Exclusion Criteria

1. Hemodynamically unstable patients.
2. Patients with septic shock from any source.
3. Patients with deep skin ulcers with exposed some organ, data osteomyelitis, vascular-nervous exposure.
4. Patients with secondary cutaneous ulcer enteral fistula.
5. Patients with cutaneous ulcer or cancer tumors.
6. Patients with cutaneous ulcer with active bleeding.
7. Patients with cutaneous ulcer necrosis.
8. Patients with cutaneous ulcer leishmania, insect bite.
9. Patients with cutaneous ulcer burns.
10. Patients who do not accept their participation in the study through informed consent.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
drenovac handcrafted	drenovac handcrafted	Patients treatment with the handicraft topical device negative pressure therapy Economic craft
Healing	Healing	Patients who were managed with traditional "conservative treatment".

Primary Outcome Measures

Name	Time	Method
Presence of granulation tissue in skin ulcers.	10 days	Presence of granulation tissue in 50% of the wound

Secondary Outcome Measures

Name	Time	Method
Leukocyte less than 11,000 mm3.	10 days	Leukocyte less than 11,000 mm3.
Breathing Rate	10 days	less than 20 rpm breathing rate.
Temperature	10 days	less than 38 ° C temperature.
Heart Rate	10 days	lower heart rate 90 bpm.