Clinical trial NCT02512159: Skin Ulcers Treatment With an Handicraft Topical Device
Official title: Effectiveness of Topical Negative Handicraft Device for Versus Traditional Conservative Treatment in Skin Ulcers Management in Lower Limb
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Foot Ulcer
Varicose Ulcer
Keywords: Diabetic foot ulcer
Foot care
Wound management
Lead sponsor: Coordinación de Investigación en Salud, Mexico
Sponsor class: OTHER_GOV
Collaborators: name: Instituto Mexicano del Seguro Social
First posted: 2015-07-30
Enrollment: 144
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Eligibility criteria: 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.

Primary outcomes:
measure: Presence of granulation tissue in skin ulcers.
timeFrame: 10 days
Secondary outcomes:
measure: Leukocyte less than 11,000 mm3.
timeFrame: 10 days
measure: Temperature
timeFrame: 10 days
measure: Breathing Rate
timeFrame: 10 days
measure: Heart Rate
timeFrame: 10 days
Other outcomes:
Locations:
Study officials:
affiliation: IMSS
name: Fany Guadalupe Pat Espadas, MCs
role: PRINCIPAL_INVESTIGATOR
affiliation: IMSS
name: Israel Augusto González González, Dr.
role: STUDY_CHAIR
affiliation: IMSS
name: Luis Sandoval Jurado, PhD
role: STUDY_DIRECTOR
affiliation: IMSS
name: Ma. Valeria Jiménez Baéz, PhD
role: STUDY_CHAIR
References:
citation: Gonzalez IG, Angel MA, Baez MV, Ruiz Flores B, de Los Angeles Martinez Ferretiz M, Woolf SV, Lopez I, Sandoval-Jurado L, Pat-Espadas FG, Cruz AA, Delgado AT. Handcrafted Vacuum-Assisted Device for Skin Ulcers Treatment Versus Traditional Therapy, Randomized Controlled Trial. World J Surg. 2017 Feb;41(2):386-393. doi: 10.1007/s00268-016-3782-9.