Skip to content

Clinical study to assess the effectiveness of the combination of Laser, Therapeutic Ultrasound, and Electrical Current associated with a Silver Nanoparticle-containing ointment in the healing of wounds in Diabetic patients

Effects of the combination of Electrophysical Agents and Silver Nanoparticles from green synthesis in the treatment of wounds in Diabetic patients: randomized clinical trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-6jn3xr9
Enrollment
Unknown
Registered
2025-09-09
Start date
2024-02-12
Completion date
Unknown
Last updated
2025-10-27

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

Conditions

Diabetic foot

Interventions

This is a randomized, clinically controlled longitudinal study conducted to evaluate the difference in wound size reduction in diabetic foot ulcers using an innovative protocol in combination with an
(ii) electrophysical protocol (high-frequency therapy + pulsed ultrasonic therapy + laser)
(iii) green synthetic gel (Aloe Vera) with silver nanoparticles
and (iv) electrophysical protocol + green synthetic gel (Aloe Vera) with silver nanoparticles. Patients in the 4 groups will undergo 2 treatment sessions per week for 3 months, for a total of 24 sessi
E02.565.280.945
E02.779.468

Sponsors

Claudio Teodoro de Souza
Lead Sponsor
Universidade Federal de Juiz de Fora
Collaborator

Eligibility

Age
50 Years to 80 Years

Inclusion criteria

Inclusion criteria: Agree to participate in the study (sign the informed consent form); diagnosis of type 1 or 2 diabetes; present chronic wounds (wounds that do not close after 6 weeks); grade 2 wound, according to Wagner's classification (DIABETIC FOOT ULCER CLASSIFICATION SYSTEMS, 2016), which is: neuropathic and deeper, often penetrating the subcutaneous tissue, has infection, but without bone involvement, purulent secretion, inflammation and cellulitis.

Exclusion criteria

Exclusion criteria: Ingesting any supplement that aids healing, in pre- and post-operative procedures (e.g. impact diet); infected ulcer accompanied by cellulitis; osteomyelitis; received or will receive radiation during the study; had constant alcohol abuse 3 months before the start of the research; diagnosed with cancer; presence of wounds containing necrotic tissue, slough or fibrin necrosis; and inability of the patient to continue attending the clinic during follow-up

Design outcomes

Primary

MeasureTime frame
To evaluate whether the retraction (in percentage) of the diabetic foot wound area is improved after the combination of electrophysical devices and nanoparticle ointment when compared with conventional treatment (control)

Secondary

MeasureTime frame
To evaluate whether better wound retraction is related to anti-inflammatory and antioxidant markers and growth factors after the combination of electrophysical devices and nanoparticle ointment when compared with conventional treatment (control)

Countries

Brazil

Contacts

Public ContactClaudio de Souza

Universidade Federal de Juiz de Fora

claudio.t.souza@gmail.com+55 32 2102-3848

Outcome results

None listed

Source: REBEC (via WHO ICTRP)