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NCT03687320: LLL&DIAB-01
Laser Therapy for At-Home Treatment of DIabetic Foot Ulcers
NA trial testing B-Cure Pro in Diabetic Foot Ulcer in 60 participants. Status unknown.
1 October 2022
Quick facts
| Lead sponsor | Erika Carmel ltd |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | treatment |
| Enrollment | 60 |
| Start date | 2 December 2019 |
| Primary completion | 1 October 2022 |
| Estimated completion | 1 October 2023 |
| Sites | 1 location across Israel |
Drugs / interventions tested
- B-Cure Pro
- Sham
Conditions studied
- Diabetic Foot Ulcer — all drugs for Diabetic Foot Ulcer →
Sponsor
Erika Carmel ltd
Who can join
Adults 18 to 90, any sex, with Diabetic Foot Ulcer. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The global prevalence of diabetes is on the rise and with it increase in prevalence of diabetic foot ulcers (DFU). These recalcitrant wounds are difficult to manage and pose a heavy economic burden. Photobiomodulation (low-level laser) is used for acceleration of wound healing. The current study is designed to evaluate the effectiveness of B-cure laser, a home-use low-level laser device, for acceleration of diabetic foot ulcer healing over standard treatment.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
RJX Improves Wound Healing in Diabetic Rats.
Uckun FM, Orhan C, Tuzcu M, Durmus AS, et al · · 2022 · cited 7× · PMID 35721744 · DOI 10.3389/fendo.2022.874291
Verify or expand the search:
- PubMed search for NCT03687320
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of B-Cure Pro
Trials testing the same drug.
- NCT04593342 — Photobiomodulation Laser Therapy Following Arthroscopic Rotator Cuff Repair · NA · completed
Other recruiting trials for Diabetic Foot Ulcer
Currently open trials in the same condition.
- NCT07161830 — Evaluating the Efficacy of OCM™ (Omeza® Complete Matrix) in the Treatment of Diabetic Foot Ulcers · NA · recruiting
- NCT07396376 — Evaluation of ELU42 Topical Spray for the Treatment of Diabetic Foot Ulcers · Phase 1, PHASE2 · recruiting
- NCT07291817 — Intermittent Negative Pressure for Patients With Diabetic Foot Ulcers (INPRESS) Study · NA · recruiting
- NCT07209358 — EDX110 Randomized Control Trial for Treatment of DFUs · NA · recruiting
- NCT06938685 — Evaluating the Efficacy NeoThelium FT in the Treatment of Diabetic Foot Ulcers · NA · recruiting
Other Erika Carmel ltd trials
Trials by the same sponsor.
- NCT05357703 — Efficacy of a Home-Use Photobiomodulation Device for the Treatment of Patients With Knee Osteoarthritis · NA · unknown
- NCT04796649 — Laser Therapy for At-Home Treatment of DIabetic Foot Ulcers (LLL&DIAB-03) · NA · unknown
- NCT04593342 — Photobiomodulation Laser Therapy Following Arthroscopic Rotator Cuff Repair · NA · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03687320 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Erika Carmel ltd
- Last refreshed: 14 December 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03687320.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing