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NCT05661474 | COMPLETED | Diabetic Foot

Fitostimoline® Hydrogel Versus Saline Gauze Dressing in Diabetic Foot Ulcers
Sponsor:

Federico II University

Information provided by (Responsible Party):

Rivelle Angela

Brief Summary:

Diabetes Mellitus (DM) is one of the most widespread metabolic diseases and the alarming rise in its prevalence worldwide poses enormous challenges. The microvascular and macrovascular complications of DM heavy impact on longevity and quality of life, and in particular diabetic foot ulcers (DFUs) are among the ten top causes of worldwide disease burden and disability Essential components of the standard care, management, and treatment of DFUs are represented by health education, strict control of blood glucose and cardiovascular risk factors, offloading, local debridement, and adequate dressing. A wide variety of dressing is available, and these include basic contact dressings (low adherence dressings such as saline gauze, paraffin gauze or simple absorbent dressings) and advanced dressings (alginate, hydrogel, films, hydrocolloid, foam). It is important underline that due to lack of evidence from head-to-head randomized controlled trials (RCTs), the relative effects of any of these dressings in DFUs remain unclear. Consequently, so far clinical evidence supporting the choice for either hydrogel or saline gauze dressing, has been related mostly on clinician perception rather than high quality evidence. Here we evaluated the efficacy and safety of Fitostimoline® hydrogel dressing versus saline gauze dressing in patients with DFUs in a monocentric, two-arm, open-label, randomized, controlled trial.

Condition or disease

Diabetic Foot

Intervention/treatment

Fitostimoline ® hydrogel group

Saline gauze group

Phase

PHASE4

Study Type : INTERVENTIONAL
Estimated Enrollment : 40 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : The Effects of Fitostimoline® Hydrogel Versus Saline Gauze Dressing in Patients With Diabetic Foot Ulcers: a Monocentric, Two-arm, Open-label, Randomized, Controlled Trial.
Actual Study Start Date : 2021-02-01
Estimated Primary Completion Date : 2022-07-12
Estimated Study Completion Date : 2022-12-12

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 80 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: 1
Criteria
Inclusion Criteria
  • * Type 1 diabetes and type 2 diabetes,
  • * adult patients with DFUs at Grades IC or IIC for a period of at least 12 weeks,
  • * an akle brachial index \>0.8,
  • * be able to understand simple instructions,
  • * provided voluntary, signed informed consent
Exclusion Criteria
  • * active infection
  • * evidence of ischaemia in the limb,
  • * osteomyelitis,
  • * gangrene,
  • * systemic inflammatory or autoimmune disease,
  • * use of corticosteroids, immunosuppressive agents, radiation therapy and chemotherapyan,
  • * known hypersensitivity to any of the dressing components.
Fitostimoline® Hydrogel Versus Saline Gauze Dressing in Diabetic Foot Ulcers

Location Details

NCT05661474

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How to Participate

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Locations

Not yet recruiting

Italy,

Department of Clinical Medicine and Surgery Federico II University

Naples, Italy, 80131