Skin Ulcers Treatment With an Handicraft Topical Device

Coordinación de Investigación en Salud, Mexico

Status and phase: Completed; Phase 4

Conditions: Foot Ulcer; Varicose Ulcer

Treatments: Procedure: drenovac handcrafted; Procedure: Healing

Study type: Interventional

Funder types: Other

Identifiers

NCT02512159

2014-2301-12

Details and patient eligibility

About

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.

Full 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

Enrollment: 144 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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144 participants in 2 patient groups

drenovac handcrafted

Experimental group

Description:

Patients treatment with the handicraft topical device negative pressure therapy Economic craft

Treatment:

Procedure: drenovac handcrafted

Healing

Active Comparator group

Description:

Patients who were managed with traditional "conservative treatment".

Treatment:

Procedure: Healing