Skin Ulcers Treatment With an Handicraft Topical Device

NCT02512159 | Completed Phase 4 DMC

• 1 other identifier: 2014-2301-12
• Study Type: interventional
• Target: 144
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Foot Ulcer; Varicose Ulcer

Keywords

Diabetic foot ulcer; Foot care; Wound management

Outcome Measures

Primary Outcomes (1)

• Presence of granulation tissue in skin ulcers.

  Presence of granulation tissue in 50% of the wound

  10 days

Secondary Outcomes (4)

• Leukocyte less than 11,000 mm3.

  10 days

• Temperature

  10 days

• Breathing Rate

  10 days

• Heart Rate

  10 days

Study Arms (2)

drenovac handcrafted

EXPERIMENTAL

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

Procedure: drenovac handcrafted

Healing

ACTIVE COMPARATOR

Patients who were managed with traditional "conservative treatment".

Procedure: Healing

Interventions

drenovac handcrafted PROCEDURE

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.

drenovac handcrafted

Healing PROCEDURE

Were handled as follows: 1. 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. 2. healing of skin ulcers were performed every 24 hours. 3. the evolution of skin ulcers was evaluated every 3 days, requesting a differential valuing of clinical and biochemical form the aforementioned variables.

Healing

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Coordinación de Investigación en Salud, Mexico: lead
• Instituto Mexicano del Seguro Social: collaborator

Related Publications (1)

• 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.

  PMID: 27822727 DERIVED

MeSH Terms

Conditions

Foot Ulcer; Varicose Ulcer; Diabetic Foot

Condition Hierarchy (Ancestors)

Foot Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Leg Ulcer; Skin Ulcer; Varicose Veins; Vascular Diseases; Cardiovascular Diseases; Diabetic Angiopathies; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Study Officials

• Fany Guadalupe Pat Espadas, MCs

  IMSS

  PRINCIPAL INVESTIGATOR

• Israel Augusto González González, Dr.

  IMSS

  STUDY CHAIR

• Luis Sandoval Jurado, PhD

  IMSS

  STUDY DIRECTOR

• Ma. Valeria Jiménez Baéz, PhD

  IMSS

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2015
• First Posted: July 30, 2015
• Study Start: March 1, 2014
• Primary Completion: October 1, 2014
• Study Completion: January 1, 2015
• Last Updated: July 30, 2015

Record last verified: 2014-02