Comparing the functional outcome between early prosthesis use and normal dressings in lower limb amputation

Assessment of functional and psychological outcomes following immediate post operative prosthesis in lower limb amputees :an open labelled randomized controlled trial - nil

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/04/108256

Enrollment

Registered

2026-04-13

Start date

Unknown

Completion date

Unknown

Last updated

2026-04-27

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

Conditions

Health Condition 1: Z896- Acquired absence of leg above knee Health Condition 2: Z895- Acquired absence of leg below knee Health Condition 3: Z899- Acquired absence of limb, unspecified

Interventions

Intervention1: Immediate post operative prosthesis group(IPOP): Amputees will be given a prosthesis immediately within 1 week of major lower limb amputation Control Intervention1: Non Immediate post o

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients undergoing unilateral lower limb amputation (BKA, above-knee or knee disaticulation). 2. Hemodynamically stable. 3. Informed consent obtained. 4. No contraindications to prosthetic fitting (e.g. ,severe wound infection, uncontrolled pain).

Exclusion criteria

Exclusion criteria: 1. Bilateral amputations. 2. Non-cooperative or non-motivated patients due to any kind of impairment, illness or otherwise. 3. Patients who are unwilling to participate due to any reason. 4. Poor stump healing potential (e.g., severe PAD, sepsis, Diabetes mellitis). 5. Age less than 18 years and more than 50 years. 6. Patients who were non ambulatory prior to amputation due to causes like spinal injury or any systemic illnesses. 7. Patient having a fracture in the same or opposite lower limb along with requiring amputation of either of the limb. 8. Amputees having amputations near the ankle and hip joint.

Design outcomes

Primary

Measure	Time frame
functional mobility outcomes using TUG test and L test in major lower limb amputees using IPOP versus those on conventional dressings.Timepoint: At 2 to 4 weeks, 3 months and 6 months	—

Secondary

Measure	Time frame
Psychological outcomes including depression, anxiety, and quality of life using Beck Depression Inventory-II (BDI-II), Generalized Anxiety Disorder- 7 (GAD-7) and SF 36 questionnaire respectively among major lower limb amputees using IPOP and standard dressing without IPOP. Timepoint: At 2 to 4 weeks, 3 months and 6 months;Factors affecting acceptance of an IPOP. Timepoint: At 2 to 4 weeks, 3 months and 6 months;Various complications related to IPOP use.Timepoint: At 2 to 4 weeks, 3 months and 6 months	—

Measure

Time frame

Psychological outcomes including depression, anxiety, and quality of life using Beck Depression Inventory-II (BDI-II), Generalized Anxiety Disorder- 7 (GAD-7) and SF 36 questionnaire respectively among major lower limb amputees using IPOP and standard dressing without IPOP. Timepoint: At 2 to 4 weeks, 3 months and 6 months;Factors affecting acceptance of an IPOP. Timepoint: At 2 to 4 weeks, 3 months and 6 months;Various complications related to IPOP use.Timepoint: At 2 to 4 weeks, 3 months and 6 months

—

Countries

India

Contacts

Public ContactDr Saket Prajapat

Post Graduate Institute OF Medical Education And Research Chandigarh

saket1908@gmail.com9811460059

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: May 1, 2026