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Completed

NCT Number: NCT02512159

Skin Ulcers Treatment With an Handicraft Topical Device

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.

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Key information

Conditions

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

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Healing

Procedure

Were handled as follows:

  • 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.
  • healing of skin ulcers were performed every 24 hours.
  • the evolution of skin ulcers was evaluated every 3 days, requesting a differential valuing of clinical and biochemical form the aforementioned variables.

Primary outcomes

  1. Presence of granulation tissue in skin ulcers.

    Time frame: 10 days

    Presence of granulation tissue in 50% of the wound

Secondary outcomes

  1. Leukocyte less than 11,000 mm3.

    Time frame: 10 days

    Leukocyte less than 11,000 mm3.

  2. Temperature

    Time frame: 10 days

    less than 38 ° C temperature.

  3. Breathing Rate

    Time frame: 10 days

    less than 20 rpm breathing rate.

  4. Heart Rate

    Time frame: 10 days

    lower heart rate 90 bpm.

Sponsors and collaborators

Lead sponsor

Coordinación de Investigación en Salud, Mexico

Other Gov

Collaborators

  • Instituto Mexicano del Seguro Social

Registry information

Official study title

Effectiveness of Topical Negative Handicraft Device for Versus Traditional Conservative Treatment in Skin Ulcers Management in Lower Limb

Important dates

Study start
2014
Primary completion
2014
Study completion
2015
First posted
Jul 30, 2015
Registry last updated
Jul 30, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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