Efficacy of Teriparatide in Diabetic Inactive Charcot Neuroarthropathy of Foot

• Status: Completed
• Trial end date: 2018-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Diabetic foot represents a major medical , social and economic problem worldwide.

Charcot's neuroarthropathy, being a common cause of diabetic foot, has been an intriguing topic of research for endocrinologists, podiatrists and surgeons. After its first description by JEAN-MARTIN CHARCOT in 1868, many theories have been put forward regarding its pathophysiology , but not much research has been done for its prevention and treatment , specially the inactive stage.

The course of Charcot 's neuroarthropathy is triphasic , with the diagnosis being usually missed in the active stage, henceforth the patients often come to us with a deformed foot. As a consequence , the osteoclastic activity in active stage renders the foot bones demineralized and weak, thus being susceptible to fracture and fragmentation.

Teriparatide is recombinant human (1-34) parathyroid molecule that has been approved for post-menopausal osteoporosis and in men with primary or secondary osteoporosis. It acts by preferentially stimulating osteoblast over osteoclast activity resulting in new bone formation and an increase in the rate of bone remodeling which manifest as an increase in skeletal mass and bone mineral density .

Keeping the pathophysiology of Charcot's foot in mind, teriparatide may be used as potential treatment for inactive Charcot's neuroarthropathy but there are no studies or randomized trials in this setting, till date. We hypothesize that teriparatide may increase the remodeling of foot bones in Charcot's neuroarthropathy, improve bone mineral density, subsequently leading to a reduction in the risk of fractures and progression of deformities. This study plans to compare the effects of teriparatide in diabetes patients with inactive Charcot's foot in a placebo controlled design.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Postgraduate Institute of Medical Education and Research
• Treatments: Hormones; Parathyroid Hormone; Teriparatide

Criteria

Inclusion Criteria:

1. Clinical criteria:

1. No warmth or redness of foot.

2. Difference in temperature between two foot < 2 degree Centigrade.

3. If deformity present , patient able to walk without aid.

4. History of resolved active Charcot's neuroarthropathy of foot.

2. Radiological criteria: Plain X-ray foot (weight bearing lateral and oblique) showing at least 3 of the following features -

1. Foot deformity.

2. Joint subluxations/dislocations.

3. Smoothening /Rounding of bone fragments.

4. Subchondral sclerosis/erosions.

5. Callus formation.

6. Joint space collapse.

Exclusion Criteria:

1. Active inflammatory phase of Charcot's neuroarthropathy.

2. Active on inactive Charcot's neuroarthropathy.

3. Osteomyelitis of foot bones.

4. Peripheral vascular disease.

5. Osteoporosis (T score less than or equal to -2.5 at lumbar spine or hip).

6. Renal failure ( estimated Glomerular Filtration Rate < 60 ml/min).

7. Previous/present bone malignancy.

8. Previous malignancy with metastases to bone.

9. Received teriparatide earlier.

10. Hyperparathyroidism.

11. Paget's disease of bone.

12. Pregnant women.

13. Received bisphosphonates in previous 18 months.

14. Patients with ulcer on the involved foot.

15. Patients previously taking Pioglitazone. -