Fitostimoline® Hydrogel Versus Saline Gauze Dressing in Diabetic Foot Ulcers

The Effects of Fitostimoline® Hydrogel Versus Saline Gauze Dressing in Patients With Diabetic Foot Ulcers: a Monocentric, Two-arm, Open-label, Randomized, Controlled Trial.

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05661474

Enrollment

Registered

2022-12-22

Start date

2021-02-01

Completion date

2022-12-12

Last updated

2022-12-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Foot

Keywords

diabetic foot, dressing, medication

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.

Interventions

DRUGFitostimoline ® hydrogel group

Treatment of DFUs with Fitostimoline® hydrogel every day for 12 weeks.

DRUGSaline gauze group

Treatment of DFUs with saline gauze every day for 12 weeks.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
the proportion of patients complete responders	12 weeks	The primary outcome was the proportion of patients that at the end of study period of 12 weeks (V6) were categorized as complete responders -complete healing of the wound defined as reepithelialisation of 100% without medications.

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026