Diabetic Foot Ulcer Clinical Trial
Official title:
The Efficacy of LL-37 Cream on Aerobic Bacteria Colonization Pattern, Inflammation Response: Interleukin 1α (IL-1α) and Tumor Necrosis Factor α (TNF-α), and Healing Rate of Diabetic Foot Ulcers
Diabetic foot ulcer (DFU) is a common complication of diabetes with global prevalence of
6.3%. Treatment of diabetic foot ulcer (DFU) is challenging with disappointing outcome. Wound
debridement, infection control, pressure relief and revascularization are main pillars of DFU
management. Various substances and modalities are being investigated for their potential
effects in treating DFU, one of which is LL-37.
In this randomized, controlled trial, 40 patients with uncomplicated DFU will be enrolled.
Patients are randomly assigned to undergo twice a week treatment with 0.5 mg/mL LL-37 cream
(treatment group) or placebo cream (control group) for 4 weeks in addition to standard wound
care. The primary outcomes are the healing rate measured by wound area and granulation index
and changes in patterns of aerobic bacteria colonization during the 4-week study duration and
changes in concentrations of IL-α and TNF-α from fluid collected from DFU on the end of the
second and third week of study compared to baseline.
n/a
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT04497805 -
Clinical Study of ALLO-ASC-SHEET in Subjects With Diabetic Wagner Grade II Foot Ulcers
|
Phase 2 | |
| Withdrawn |
NCT03675269 -
Adjunctive Hyperbaric Oxygen Therapy (HBOT) for Lower Extermity Diabetic Ulcer:
|
N/A | |
| Completed |
NCT04624516 -
Effect of Self-foot Exercise on the Incidence of Plantar Foot Diabetic Ulcer Recurrence
|
N/A | |
| Not yet recruiting |
NCT06439667 -
VIRTUALLY SUPERVISED TELE-EXERCISE PLATFORM FOR ACCELERATING PLANTAR WOUND HEALING
|
||
| Recruiting |
NCT05608187 -
Evaluating Safety and Biological Effect on Wound Healing of ILP100-Topical in Subjects With Diabetic Foot Ulcers
|
Phase 2 | |
| Not yet recruiting |
NCT06278935 -
Lifestyle Tailored Offloading for Diabetic Foot Ulcers
|
N/A | |
| Not yet recruiting |
NCT06437028 -
Evaluating the Efficacy of Perinatal Membrane Allografts for the Treatment of Diabetic Foot Ulcers.
|
N/A | |
| Withdrawn |
NCT05024656 -
AmnioExcel® Plus vs SOC in the Management of Diabetic Foot Ulcers
|
N/A | |
| Terminated |
NCT02202668 -
Transcutaneous Raman Spectroscope (TRS) Analyses of Diabetic Foot Ulcers
|
N/A | |
| Terminated |
NCT01966380 -
Proof of Concept (Design Validation) in Patient With Hard to Heal Wounds Such as Pressure Ulcer, Diabetic Foot Ulcer and Leg Ulcer, Leia
|
Phase 2 | |
| Completed |
NCT01951768 -
Efficacy and Safety of Garamycin® Sponge in Diabetic Patients With a Moderate or Severe Foot Ulcer Infection
|
Phase 4 | |
| Completed |
NCT01657474 -
Comparative Study of Two Application Regimens of Amniotic Membrane Wound Graft In the Management of Diabetic Foot Ulcers
|
N/A | |
| Active, not recruiting |
NCT00389636 -
TheraGauze™ Alone and Regranex®Gel 0.01% Plus TheraGauze™ in the Treatment of Wagner Stage I Diabetic Foot Ulcers
|
N/A | |
| Completed |
NCT01181440 -
Dermagraft(R) for the Treatment of Patients With Diabetic Foot Ulcers
|
Phase 3 | |
| Enrolling by invitation |
NCT05888259 -
Plantar Pressure Distribution in Diabetic Foot Ulcer
|
N/A | |
| Completed |
NCT04054804 -
Digital Foot Check by Using the D-Foot, a New Software
|
||
| Not yet recruiting |
NCT05877378 -
Efficacy of PICO Single-use System in Chronic Ulcers
|
N/A | |
| Recruiting |
NCT06037369 -
The Short Message-based Customized Standardized
|
N/A | |
| Completed |
NCT03312595 -
Clinical Outcomes After Treatment With RestrataTM Wound Matrix in Diabetic Foot Ulcers (DFU)
|
N/A | |
| Recruiting |
NCT04564443 -
A Unique Micro Water Jet Technology Device Versus Standard Debridement in the Treatment of Diabetic Foot
|
N/A |