Effectiveness of Topical Negative Handicraft Device for Versus Traditional Conservative Treatment in Skin Ulcers Management in Lower Limb
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 144
- Primary Endpoint
- Presence of granulation tissue in skin ulcers.
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Care Provider)
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
drenovac handcrafted
Patients treatment with the handicraft topical device negative pressure therapy Economic craft
Intervention: drenovac handcrafted (Procedure)
Healing
Patients who were managed with traditional "conservative treatment".
Intervention: Healing (Procedure)
Outcomes
Primary Outcomes
Presence of granulation tissue in skin ulcers.
Time Frame: 10 days
Presence of granulation tissue in 50% of the wound
Secondary Outcomes
- Leukocyte less than 11,000 mm3.(10 days)
- Breathing Rate(10 days)
- Temperature(10 days)
- Heart Rate(10 days)